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Trial Outcomes & Findings for Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT03703102)

NCT ID: NCT03703102

Last Updated: 2024-04-26

Results Overview

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

274 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2024-04-26

Participant Flow

The screening period began in September 2018. A total of 61 sites in four countries (Canada, Germany, Japan, and the United States) screened 351 patients and enrolled 274. The screening period closed in September 2019.

In Treatment Period A, randomized subjects received either study drug or placebo for 18 weeks. In Treatment Period B, the patients randomized to the placebo arm received study drug for 18 weeks. There was no treatment change for patients randomized to study drug arms. One subject who was randomized to the 600 mg Q4W group did not receive any study drug due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.

Participant milestones

Participant milestones
Measure
KHK4083 150 mg SC Q4W
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 300 mg SC Q2W
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
Overall Study
STARTED
54
53
55
54
57
Overall Study
Completed Treatment Period A
42
41
42
46
34
Overall Study
Completed Treatment Period B
33
39
37
38
26
Overall Study
COMPLETED
32
38
33
37
24
Overall Study
NOT COMPLETED
22
15
22
17
33

Reasons for withdrawal

Reasons for withdrawal
Measure
KHK4083 150 mg SC Q4W
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 300 mg SC Q2W
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
Overall Study
Adverse Event
4
3
7
3
13
Overall Study
Lack of Efficacy
4
0
1
4
1
Overall Study
Lost to Follow-up
0
0
1
2
2
Overall Study
Physician Decision
2
2
2
2
4
Overall Study
Withdrawal by Subject
7
5
5
5
9
Overall Study
Ineligibility
0
0
1
0
0
Overall Study
Protocol Deviation
4
4
3
0
0
Overall Study
Non-Compliance with Study Drug
1
1
2
1
4

Baseline Characteristics

Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
KHK4083 150 mg SC Q4W
n=54 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=53 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 300 mg SC Q2W
n=55 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
Total
n=273 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Age, Categorical
Between 18 and 65 years
52 Participants
n=99 Participants
51 Participants
n=107 Participants
51 Participants
n=206 Participants
49 Participants
n=7 Participants
52 Participants
n=31 Participants
255 Participants
n=30 Participants
Age, Categorical
>=65 years
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
5 Participants
n=7 Participants
5 Participants
n=31 Participants
18 Participants
n=30 Participants
Age, Continuous
37.4 years
n=99 Participants
38.9 years
n=107 Participants
37.5 years
n=206 Participants
37.3 years
n=7 Participants
38.7 years
n=31 Participants
38.0 years
n=30 Participants
Sex: Female, Male
Female
17 Participants
n=99 Participants
22 Participants
n=107 Participants
24 Participants
n=206 Participants
24 Participants
n=7 Participants
26 Participants
n=31 Participants
113 Participants
n=30 Participants
Sex: Female, Male
Male
37 Participants
n=99 Participants
31 Participants
n=107 Participants
31 Participants
n=206 Participants
30 Participants
n=7 Participants
31 Participants
n=31 Participants
160 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
7 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
51 Participants
n=99 Participants
51 Participants
n=107 Participants
54 Participants
n=206 Participants
53 Participants
n=7 Participants
54 Participants
n=31 Participants
263 Participants
n=30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
3 Participants
n=30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Asian
36 Participants
n=99 Participants
32 Participants
n=107 Participants
37 Participants
n=206 Participants
33 Participants
n=7 Participants
37 Participants
n=31 Participants
175 Participants
n=30 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
1 Participants
n=7 Participants
6 Participants
n=31 Participants
13 Participants
n=30 Participants
Race (NIH/OMB)
White
14 Participants
n=99 Participants
20 Participants
n=107 Participants
16 Participants
n=206 Participants
20 Participants
n=7 Participants
14 Participants
n=31 Participants
84 Participants
n=30 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
1 Participants
n=30 Participants
Region of Enrollment
Canada
4 participants
n=99 Participants
5 participants
n=107 Participants
5 participants
n=206 Participants
4 participants
n=7 Participants
7 participants
n=31 Participants
25 participants
n=30 Participants
Region of Enrollment
United States
11 participants
n=99 Participants
10 participants
n=107 Participants
11 participants
n=206 Participants
11 participants
n=7 Participants
13 participants
n=31 Participants
56 participants
n=30 Participants
Region of Enrollment
Japan
32 participants
n=99 Participants
30 participants
n=107 Participants
33 participants
n=206 Participants
32 participants
n=7 Participants
32 participants
n=31 Participants
159 participants
n=30 Participants
Region of Enrollment
Germany
7 participants
n=99 Participants
8 participants
n=107 Participants
6 participants
n=206 Participants
7 participants
n=7 Participants
5 participants
n=31 Participants
33 participants
n=30 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
-61.07 percentage of score change
Interval -75.19 to -46.96
-57.35 percentage of score change
Interval -71.27 to -43.43
-15.01 percentage of score change
Interval -28.6 to -1.43
-48.33 percentage of score change
Interval -62.62 to -34.04
-49.72 percentage of score change
Interval -62.47 to -35.17

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
Achieved EASI-50 at Week 16
36 Participants
35 Participants
17 Participants
30 Participants
31 Participants
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
achieved EASI-75 at Week 16
28 Participants
21 Participants
6 Participants
23 Participants
21 Participants
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
achieved EASI-90 at Week 16
19 Participants
10 Participants
2 Participants
10 Participants
6 Participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
-23.3 score on a scale
Standard Deviation 9.0
-19.9 score on a scale
Standard Deviation 11.8
-9.8 score on a scale
Standard Deviation 13.0
-22.5 score on a scale
Standard Deviation 14.7
-20.7 score on a scale
Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
-30.44 score on a scale
Interval -37.27 to -23.61
-27.65 score on a scale
Interval -34.39 to -20.91
-8.09 score on a scale
Interval -14.65 to -1.53
-23.71 score on a scale
Interval -30.72 to -16.69
-23.86 score on a scale
Interval -30.92 to -16.81

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
-46.69 percentage of score change
Interval -56.77 to -36.61
-40.76 percentage of score change
Interval -50.7 to -30.81
-11.90 percentage of score change
Interval -21.59 to -2.22
-34.86 percentage of score change
Interval -45.2 to -24.51
-35.13 percentage of score change
Interval -45.54 to -24.72

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
16 Participants
10 Participants
1 Participants
10 Participants
8 Participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

The Investigator will calculate the percentage (%) of the total body surface area affected by AD.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
-27.92 percentage of total BSA involvement
Interval -35.3 to -20.54
-25.04 percentage of total BSA involvement
Interval -32.33 to -17.76
-7.87 percentage of total BSA involvement
Interval -14.96 to -0.77
-22.86 percentage of total BSA involvement
Interval -30.3 to -15.42
-21.48 percentage of total BSA involvement
Interval -29.07 to -13.89

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
-3.60 score on a scale
Interval -4.44 to -2.75
-2.81 score on a scale
Interval -3.64 to -1.97
-1.31 score on a scale
Interval -2.12 to -0.49
-2.04 score on a scale
Interval -2.9 to -1.18
-3.02 score on a scale
Interval -3.9 to -2.15

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
-47.99 percentage of score change
Interval -61.71 to -34.26
-36.83 percentage of score change
Interval -50.41 to -23.25
-6.18 percentage of score change
Interval -6.18 to 7.01
-25.57 percentage of score change
Interval -39.48 to -11.66
-34.38 percentage of score change
Interval -48.56 to -20.21

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
-2.59 score on a scale
Interval -3.48 to -1.69
-2.00 score on a scale
Interval -2.9 to -1.11
-0.01 score on a scale
Interval -0.87 to 0.86
-1.09 score on a scale
Interval -2.01 to -0.18
-1.93 score on a scale
Interval -2.86 to -1.0

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
-41.58 percentage of score change
Interval -78.3 to -4.86
-33.17 percentage of score change
Interval -69.08 to 2.74
-46.54 percentage of score change
Interval -100.55 to -8.89
-8.19 percentage of score change
Interval -44.32 to 27.95
-7.02 percentage of score change
Interval -44.96 to 30.93

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.

DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
-6.28 score on a scale
Interval -8.38 to -4.18
-4.93 score on a scale
Interval -7.01 to -2.84
0.19 score on a scale
Interval -1.88 to 2.27
-2.59 score on a scale
Interval -4.73 to -0.44
-4.66 score on a scale
Interval -6.89 to -2.43

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
EASI Score at Each Time Point
EASI Score at Week 26
4.3 score on a scale
Interval 0.0 to 36.0
5.8 score on a scale
Interval 0.0 to 46.0
10.8 score on a scale
Interval 0.0 to 48.0
8.2 score on a scale
Interval 0.0 to 72.0
6.8 score on a scale
Interval 0.0 to 35.0
EASI Score at Each Time Point
EASI Score at Week 28
4.7 score on a scale
Interval 0.0 to 37.0
4.8 score on a scale
Interval 0.0 to 28.0
9.8 score on a scale
Interval 0.0 to 46.0
7.7 score on a scale
Interval 0.0 to 72.0
6.8 score on a scale
Interval 0.0 to 29.0
EASI Score at Each Time Point
EASI Score at Week 30
4.1 score on a scale
Interval 0.0 to 50.0
3.8 score on a scale
Interval 0.0 to 24.0
8.4 score on a scale
Interval 0.0 to 38.0
6.5 score on a scale
Interval 0.0 to 51.0
6.1 score on a scale
Interval 0.0 to 26.0
EASI Score at Each Time Point
EASI Score at Week 32
2.9 score on a scale
Interval 0.0 to 20.0
3.3 score on a scale
Interval 0.0 to 18.0
6.3 score on a scale
Interval 0.0 to 27.0
6.4 score on a scale
Interval 0.0 to 64.0
5.2 score on a scale
Interval 0.0 to 25.0
EASI Score at Each Time Point
EASI Score at Week 34
2.6 score on a scale
Interval 0.0 to 19.0
3.4 score on a scale
Interval 0.0 to 29.0
5.7 score on a scale
Interval 0.0 to 30.0
5.9 score on a scale
Interval 0.0 to 67.0
5.8 score on a scale
Interval 0.0 to 27.0
EASI Score at Each Time Point
EASI Score at Baseline
31.6 score on a scale
Interval 16.0 to 64.0
31.1 score on a scale
Interval 16.0 to 60.0
29.2 score on a scale
Interval 16.0 to 68.0
33.2 score on a scale
Interval 16.0 to 63.0
32.5 score on a scale
Interval 16.0 to 69.0
EASI Score at Each Time Point
EASI Score at Week 1
28.6 score on a scale
Interval 6.0 to 69.0
29.4 score on a scale
Interval 2.0 to 57.0
28.5 score on a scale
Interval 6.0 to 62.0
33.0 score on a scale
Interval 10.0 to 65.0
29.5 score on a scale
Interval 6.0 to 58.0
EASI Score at Each Time Point
EASI Score at Week 2
25.6 score on a scale
Interval 2.0 to 66.0
27.2 score on a scale
Interval 0.0 to 58.0
28.1 score on a scale
Interval 5.0 to 71.0
31.7 score on a scale
Interval 5.0 to 67.0
27.6 score on a scale
Interval 6.0 to 60.0
EASI Score at Each Time Point
EASI Score at Week 4
22.4 score on a scale
Interval 2.0 to 49.0
23.4 score on a scale
Interval 1.0 to 68.0
28.8 score on a scale
Interval 2.0 to 71.0
27.3 score on a scale
Interval 0.0 to 71.0
26.3 score on a scale
Interval 5.0 to 56.0
EASI Score at Each Time Point
EASI Score at Week 6
17.6 score on a scale
Interval 0.0 to 52.0
19.6 score on a scale
Interval 0.0 to 52.0
27.9 score on a scale
Interval 2.0 to 71.0
24.7 score on a scale
Interval 0.0 to 66.0
21.6 score on a scale
Interval 0.0 to 57.0
EASI Score at Each Time Point
EASI Score at Week 8
15.2 score on a scale
Interval 1.0 to 50.0
17.3 score on a scale
Interval 0.0 to 51.0
25.8 score on a scale
Interval 3.0 to 67.0
20.3 score on a scale
Interval 0.0 to 63.0
17.6 score on a scale
Interval 0.0 to 55.0
EASI Score at Each Time Point
EASI Score at Week 10
12.9 score on a scale
Interval 0.0 to 47.0
16.1 score on a scale
Interval 0.0 to 46.0
25.5 score on a scale
Interval 2.0 to 72.0
16.5 score on a scale
Interval 0.0 to 72.0
15.8 score on a scale
Interval 0.0 to 65.0
EASI Score at Each Time Point
EASI Score at Week 12
10.5 score on a scale
Interval 0.0 to 47.0
14.9 score on a scale
Interval 1.0 to 45.0
23.6 score on a scale
Interval 1.0 to 72.0
14.7 score on a scale
Interval 0.0 to 72.0
13.9 score on a scale
Interval 0.0 to 53.0
EASI Score at Each Time Point
EASI Score at Week 14
9.8 score on a scale
Interval 0.0 to 45.0
12.1 score on a scale
Interval 0.0 to 44.0
22.7 score on a scale
Interval 1.0 to 71.0
12.6 score on a scale
Interval 0.0 to 62.0
12.6 score on a scale
Interval 0.0 to 55.0
EASI Score at Each Time Point
EASI Score at Week 15
9.0 score on a scale
Interval 0.0 to 48.0
11.6 score on a scale
Interval 0.0 to 37.0
20.6 score on a scale
Interval 0.0 to 72.0
10.8 score on a scale
Interval 0.0 to 59.0
12.6 score on a scale
Interval 0.0 to 50.0
EASI Score at Each Time Point
EASI Score at Week 16
8.0 score on a scale
Interval 0.0 to 40.0
11.1 score on a scale
Interval 0.0 to 41.0
20.4 score on a scale
Interval 0.0 to 72.0
10.8 score on a scale
Interval 0.0 to 62.0
11.8 score on a scale
Interval 0.0 to 48.0
EASI Score at Each Time Point
EASI Score at Week 18
8.7 score on a scale
Interval 0.0 to 39.0
10.6 score on a scale
Interval 0.0 to 60.0
22.2 score on a scale
Interval 0.0 to 72.0
10.5 score on a scale
Interval 0.0 to 60.0
11.0 score on a scale
Interval 0.0 to 41.0
EASI Score at Each Time Point
EASI Score at Week 20
7.2 score on a scale
Interval 0.0 to 32.0
8.1 score on a scale
Interval 0.0 to 38.0
20.8 score on a scale
Interval 0.0 to 62.0
10.0 score on a scale
Interval 0.0 to 72.0
9.5 score on a scale
Interval 0.0 to 39.0
EASI Score at Each Time Point
EASI Score at Week 22
6.5 score on a scale
Interval 0.0 to 38.0
6.0 score on a scale
Interval 0.0 to 36.0
16.6 score on a scale
Interval 0.0 to 60.0
8.9 score on a scale
Interval 0.0 to 72.0
7.5 score on a scale
Interval 0.0 to 37.0
EASI Score at Each Time Point
EASI Score at Week 24
5.0 score on a scale
Interval 0.0 to 37.0
6.2 score on a scale
Interval 0.0 to 46.0
15.9 score on a scale
Interval 0.0 to 53.0
9.4 score on a scale
Interval 0.0 to 72.0
7.4 score on a scale
Interval 0.0 to 37.0
EASI Score at Each Time Point
EASI Score at Week 36
2.1 score on a scale
Interval 0.0 to 16.0
3.5 score on a scale
Interval 0.0 to 17.0
6.3 score on a scale
Interval 0.0 to 42.0
5.6 score on a scale
Interval 0.0 to 62.0
4.8 score on a scale
Interval 0.0 to 26.0
EASI Score at Each Time Point
EASI Score at Week 40
2.7 score on a scale
Interval 0.0 to 30.0
3.1 score on a scale
Interval 0.0 to 13.0
5.5 score on a scale
Interval 0.0 to 30.0
4.1 score on a scale
Interval 0.0 to 25.0
3.8 score on a scale
Interval 0.0 to 21.0
EASI Score at Each Time Point
EASI Score at Week 44
1.5 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 12.0
2.8 score on a scale
Interval 0.0 to 17.0
3.5 score on a scale
Interval 0.0 to 30.0
5.8 score on a scale
Interval 0.0 to 72.0
EASI Score at Each Time Point
EASI Score at Week 48
1.6 score on a scale
Interval 0.0 to 7.0
2.5 score on a scale
Interval 0.0 to 12.0
3.2 score on a scale
Interval 0.0 to 19.0
6.5 score on a scale
Interval 0.0 to 33.0
3.0 score on a scale
Interval 0.0 to 20.0
EASI Score at Each Time Point
EASI Score at Week 52
2.2 score on a scale
Interval 0.0 to 19.0
2.3 score on a scale
Interval 0.0 to 10.0
2.6 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 12.0
2.9 score on a scale
Interval 0.0 to 20.0
EASI Score at Each Time Point
EASI Score at Week 56
2.4 score on a scale
Interval 0.0 to 18.0
2.8 score on a scale
Interval 0.0 to 14.0
3.2 score on a scale
Interval 0.0 to 11.0
4.2 score on a scale
Interval 0.0 to 22.0
4.7 score on a scale
Interval 0.0 to 32.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 14
-71.1 percentage of score change
Interval -100.0 to 36.0
-61.5 percentage of score change
Interval -100.0 to 0.0
-32.1 percentage of score change
Interval -95.0 to 30.0
-62.5 percentage of score change
Interval -100.0 to 7.0
-62.1 percentage of score change
Interval -100.0 to 12.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 1
-8.5 percentage of score change
Interval -72.0 to 100.0
-7.0 percentage of score change
Interval -89.0 to 96.0
-2.9 percentage of score change
Interval -63.0 to 114.0
-2.5 percentage of score change
Interval -55.0 to 48.0
-9.5 percentage of score change
Interval -68.0 to 31.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 2
-18.4 percentage of score change
Interval -88.0 to 128.0
-15.6 percentage of score change
Interval -100.0 to 79.0
-2.6 percentage of score change
Interval -72.0 to 154.0
-6.7 percentage of score change
Interval -71.0 to 71.0
-14.3 percentage of score change
Interval -75.0 to 31.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 4
-26.4 percentage of score change
Interval -92.0 to 167.0
-24.6 percentage of score change
Interval -96.0 to 57.0
-8.5 percentage of score change
Interval -89.0 to 58.0
-19.6 percentage of score change
Interval -100.0 to 78.0
-19.4 percentage of score change
Interval -74.0 to 42.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 6
-43.4 percentage of score change
Interval -100.0 to 94.0
-35.8 percentage of score change
Interval -100.0 to 70.0
-11.1 percentage of score change
Interval -89.0 to 76.0
-28.8 percentage of score change
Interval -100.0 to 48.0
-32.5 percentage of score change
Interval -100.0 to 54.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 8
-52.2 percentage of score change
Interval -97.0 to 37.0
-42.1 percentage of score change
Interval -100.0 to 50.0
-19.2 percentage of score change
Interval -83.0 to 150.0
-40.3 percentage of score change
Interval -100.0 to 118.0
-45.5 percentage of score change
Interval -100.0 to 29.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 10
-60.4 percentage of score change
Interval -100.0 to 25.0
-48.2 percentage of score change
Interval -100.0 to 50.0
-21.1 percentage of score change
Interval -91.0 to 66.0
-51.5 percentage of score change
Interval -100.0 to 45.0
-51.9 percentage of score change
Interval -100.0 to 86.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 15
-74.1 percentage of score change
Interval -100.0 to -9.0
-62.6 percentage of score change
Interval -100.0 to 19.0
-35.3 percentage of score change
Interval -100.0 to 81.0
-67.1 percentage of score change
Interval -100.0 to 2.0
-62.2 percentage of score change
Interval -100.0 to 6.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 12
-68.3 percentage of score change
Interval -100.0 to 26.0
-50.9 percentage of score change
Interval -96.0 to 12.0
-29.5 percentage of score change
Interval -95.0 to 61.0
-56.7 percentage of score change
Interval -100.0 to 24.0
-58.4 percentage of score change
Interval -100.0 to 9.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 16
-77.2 percentage of score change
Interval -100.0 to -20.0
-63.6 percentage of score change
Interval -100.0 to 52.0
-37.4 percentage of score change
Interval -100.0 to 81.0
-67.0 percentage of score change
Interval -100.0 to 18.0
-63.2 percentage of score change
Interval -100.0 to 6.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 18
-75.5 percentage of score change
Interval -100.0 to -13.0
-63.9 percentage of score change
Interval -100.0 to 233.0
-32.6 percentage of score change
Interval -100.0 to 81.0
-67.1 percentage of score change
Interval -100.0 to 10.0
-66.1 percentage of score change
Interval -100.0 to -6.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 20
-79.0 percentage of score change
Interval -100.0 to -12.0
-74.4 percentage of score change
Interval -100.0 to 11.0
-37.9 percentage of score change
Interval -100.0 to 95.0
-69.7 percentage of score change
Interval -100.0 to 24.0
-70.6 percentage of score change
Interval -100.0 to 0.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 22
-80.8 percentage of score change
Interval -100.0 to -12.0
-79.4 percentage of score change
Interval -100.0 to 33.0
-49.3 percentage of score change
Interval -100.0 to 95.0
-74.3 percentage of score change
Interval -100.0 to 24.0
-75.6 percentage of score change
Interval -100.0 to -5.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 24
-85.3 percentage of score change
Interval -100.0 to 9.0
-80.4 percentage of score change
Interval -100.0 to 15.0
-49.7 percentage of score change
Interval -100.0 to 105.0
-71.7 percentage of score change
Interval -100.0 to 24.0
-75.5 percentage of score change
Interval -100.0 to -5.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 26
-86.3 percentage of score change
Interval -100.0 to -18.0
-81.0 percentage of score change
Interval -100.0 to 15.0
-70.1 percentage of score change
Interval -100.0 to 20.0
-75.3 percentage of score change
Interval -100.0 to 24.0
-78.2 percentage of score change
Interval -100.0 to -23.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 28
-84.8 percentage of score change
Interval -100.0 to 32.0
-83.9 percentage of score change
Interval -100.0 to -7.0
-70.6 percentage of score change
Interval -100.0 to 15.0
-78.7 percentage of score change
Interval -100.0 to 24.0
-77.5 percentage of score change
Interval -100.0 to -20.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 30
-87.3 percentage of score change
Interval -100.0 to 11.0
-86.5 percentage of score change
Interval -100.0 to -14.0
-74.5 percentage of score change
Interval -100.0 to -6.0
-80.8 percentage of score change
Interval -100.0 to -12.0
-81.1 percentage of score change
Interval -100.0 to -31.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 32
-90.5 percentage of score change
Interval -100.0 to -56.0
-87.9 percentage of score change
Interval -100.0 to -36.0
-82.4 percentage of score change
Interval -100.0 to -44.0
-82.5 percentage of score change
Interval -100.0 to 10.0
-82.7 percentage of score change
Interval -100.0 to -31.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 34
-91.3 percentage of score change
Interval -100.0 to -52.0
-87.1 percentage of score change
Interval -100.0 to 4.0
-81.8 percentage of score change
Interval -100.0 to -18.0
-83.6 percentage of score change
Interval -100.0 to 16.0
-80.5 percentage of score change
Interval -100.0 to -23.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 36
-93.0 percentage of score change
Interval -100.0 to -62.0
-87.2 percentage of score change
Interval -100.0 to -39.0
-82.2 percentage of score change
Interval -100.0 to 5.0
-84.5 percentage of score change
Interval -100.0 to 7.0
-83.5 percentage of score change
Interval -100.0 to -24.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 40
-91.7 percentage of score change
Interval -100.0 to -33.0
-88.4 percentage of score change
Interval -100.0 to -54.0
-82.3 percentage of score change
Interval -100.0 to 0.0
-88.0 percentage of score change
Interval -100.0 to -36.0
-86.9 percentage of score change
Interval -100.0 to -52.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 44
-94.8 percentage of score change
Interval -100.0 to -82.0
-88.5 percentage of score change
Interval -100.0 to -41.0
-86.7 percentage of score change
Interval -100.0 to 0.0
-89.1 percentage of score change
Interval -100.0 to -14.0
-81.7 percentage of score change
Interval -100.0 to 106.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 48
-94.3 percentage of score change
Interval -100.0 to -78.0
-91.6 percentage of score change
Interval -100.0 to -57.0
-85.0 percentage of score change
Interval -100.0 to 12.0
-84.5 percentage of score change
Interval -100.0 to -11.0
-90.8 percentage of score change
Interval -100.0 to -56.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 52
-93.2 percentage of score change
Interval -100.0 to -66.0
-92.4 percentage of score change
Interval -100.0 to -58.0
-90.2 percentage of score change
Interval -100.0 to -63.0
-90.4 percentage of score change
Interval -100.0 to -42.0
-92.2 percentage of score change
Interval -100.0 to -56.0
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 56
-90.3 percentage of score change
Interval -100.0 to -36.0
-90.4 percentage of score change
Interval -100.0 to -57.0
-88.3 percentage of score change
Interval -100.0 to -50.0
-87.4 percentage of score change
Interval -100.0 to -32.0
-88.3 percentage of score change
Interval -100.0 to -35.0

SECONDARY outcome

Timeframe: 56 Weeks

In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 36
28 Participants
21 Participants
13 Participants
18 Participants
19 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 26
26 Participants
20 Participants
6 Participants
14 Participants
16 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 28
25 Participants
17 Participants
5 Participants
15 Participants
14 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 30
25 Participants
24 Participants
8 Participants
14 Participants
18 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 44
24 Participants
20 Participants
12 Participants
14 Participants
24 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 32
27 Participants
25 Participants
11 Participants
16 Participants
17 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 34
27 Participants
24 Participants
11 Participants
19 Participants
15 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 40
23 Participants
18 Participants
13 Participants
15 Participants
19 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 4
1 Participants
2 Participants
0 Participants
2 Participants
0 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 6
3 Participants
2 Participants
0 Participants
2 Participants
1 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 48
22 Participants
18 Participants
11 Participants
14 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 52
17 Participants
19 Participants
11 Participants
12 Participants
24 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 56
13 Participants
15 Participants
8 Participants
13 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 40
29 Participants
30 Participants
20 Participants
24 Participants
34 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 1
7 Participants
3 Participants
1 Participants
1 Participants
2 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 2
11 Participants
8 Participants
3 Participants
5 Participants
7 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 4
14 Participants
11 Participants
2 Participants
10 Participants
9 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 6
22 Participants
20 Participants
5 Participants
12 Participants
17 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 8
29 Participants
24 Participants
10 Participants
18 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 10
32 Participants
26 Participants
10 Participants
26 Participants
29 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 12
34 Participants
27 Participants
13 Participants
28 Participants
31 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 14
33 Participants
34 Participants
12 Participants
31 Participants
31 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 15
33 Participants
31 Participants
15 Participants
30 Participants
30 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 16
36 Participants
35 Participants
17 Participants
30 Participants
31 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 18
34 Participants
36 Participants
16 Participants
32 Participants
32 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 20
36 Participants
39 Participants
17 Participants
33 Participants
32 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 22
36 Participants
41 Participants
19 Participants
32 Participants
34 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 24
39 Participants
40 Participants
19 Participants
32 Participants
34 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 26
35 Participants
39 Participants
21 Participants
31 Participants
31 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 28
34 Participants
38 Participants
21 Participants
30 Participants
33 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 30
36 Participants
39 Participants
21 Participants
30 Participants
35 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 32
37 Participants
38 Participants
21 Participants
30 Participants
35 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 34
35 Participants
35 Participants
20 Participants
31 Participants
36 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 36
36 Participants
36 Participants
23 Participants
31 Participants
34 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 44
29 Participants
29 Participants
18 Participants
23 Participants
31 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 48
28 Participants
26 Participants
16 Participants
19 Participants
32 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 52
23 Participants
24 Participants
17 Participants
17 Participants
33 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 56
17 Participants
20 Participants
16 Participants
18 Participants
25 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 1
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 24
34 Participants
29 Participants
11 Participants
25 Participants
28 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 2
3 Participants
3 Participants
0 Participants
0 Participants
1 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 4
6 Participants
7 Participants
1 Participants
6 Participants
0 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 15
25 Participants
18 Participants
7 Participants
19 Participants
18 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 6
12 Participants
8 Participants
2 Participants
5 Participants
5 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 8
10 Participants
11 Participants
3 Participants
11 Participants
7 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 10
17 Participants
13 Participants
5 Participants
11 Participants
11 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 12
24 Participants
16 Participants
4 Participants
13 Participants
14 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 14
25 Participants
17 Participants
5 Participants
17 Participants
17 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 16
28 Participants
21 Participants
6 Participants
23 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 18
26 Participants
27 Participants
8 Participants
22 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 20
26 Participants
27 Participants
8 Participants
24 Participants
21 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 22
30 Participants
30 Participants
11 Participants
27 Participants
29 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 26
34 Participants
33 Participants
17 Participants
25 Participants
29 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 14
16 Participants
8 Participants
2 Participants
6 Participants
6 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 28
33 Participants
32 Participants
17 Participants
26 Participants
26 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 30
32 Participants
32 Participants
18 Participants
24 Participants
26 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 32
31 Participants
35 Participants
19 Participants
23 Participants
29 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 8
7 Participants
4 Participants
0 Participants
4 Participants
3 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 10
8 Participants
5 Participants
1 Participants
7 Participants
3 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 12
10 Participants
5 Participants
26 Participants
9 Participants
4 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 15
17 Participants
8 Participants
3 Participants
11 Participants
6 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 40
27 Participants
26 Participants
17 Participants
23 Participants
28 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 34
30 Participants
31 Participants
19 Participants
23 Participants
27 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 36
33 Participants
31 Participants
20 Participants
27 Participants
30 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 16
19 Participants
10 Participants
2 Participants
10 Participants
6 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 44
29 Participants
25 Participants
17 Participants
21 Participants
27 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 48
28 Participants
24 Participants
15 Participants
19 Participants
30 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 52
22 Participants
22 Participants
14 Participants
16 Participants
30 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 56
16 Participants
17 Participants
14 Participants
15 Participants
24 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 1
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 2
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 18
15 Participants
13 Participants
3 Participants
9 Participants
11 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 20
17 Participants
14 Participants
3 Participants
14 Participants
14 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 22
20 Participants
17 Participants
5 Participants
16 Participants
15 Participants
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 24
26 Participants
16 Participants
6 Participants
14 Participants
14 Participants

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 10
39.13 score on a scale
Interval 0.6 to 75.8
45.50 score on a scale
Interval 9.4 to 90.1
58.85 score on a scale
Interval 20.3 to 103.1
42.42 score on a scale
Interval 0.6 to 100.7
45.15 score on a scale
Interval 7.4 to 85.7
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 12
33.82 score on a scale
Interval 4.0 to 68.0
43.68 score on a scale
Interval 9.7 to 89.4
57.15 score on a scale
Interval 15.3 to 102.9
41.07 score on a scale
Interval 1.3 to 102.5
41.98 score on a scale
Interval 8.0 to 84.9
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 14
31.69 score on a scale
Interval 3.8 to 67.6
39.41 score on a scale
Interval 1.0 to 88.1
54.68 score on a scale
Interval 14.1 to 96.4
39.51 score on a scale
Interval 1.3 to 101.6
39.75 score on a scale
Interval 11.7 to 88.9
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 15
30.03 score on a scale
Interval 0.5 to 76.9
37.46 score on a scale
Interval 0.9 to 69.3
51.66 score on a scale
Interval 16.7 to 96.8
35.79 score on a scale
Interval 0.5 to 93.7
38.88 score on a scale
Interval 2.3 to 81.9
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 16
28.31 score on a scale
Interval 3.5 to 70.1
35.76 score on a scale
Interval 1.1 to 72.4
51.80 score on a scale
Interval 16.3 to 97.0
34.70 score on a scale
Interval 0.8 to 97.8
37.82 score on a scale
Interval 2.0 to 77.8
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 18
30.14 score on a scale
Interval 0.3 to 64.5
34.80 score on a scale
Interval 6.2 to 83.8
51.99 score on a scale
Interval 19.6 to 97.6
36.44 score on a scale
Interval 0.4 to 97.8
36.01 score on a scale
Interval 1.4 to 71.3
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 20
27.59 score on a scale
Interval 0.2 to 66.4
31.35 score on a scale
Interval 0.2 to 74.2
48.17 score on a scale
Interval 13.0 to 90.6
33.88 score on a scale
Interval 0.3 to 100.3
33.86 score on a scale
Interval 1.3 to 63.8
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 22
25.14 score on a scale
Interval 0.2 to 57.5
28.21 score on a scale
Interval 0.2 to 64.0
45.07 score on a scale
Interval 0.6 to 88.8
31.69 score on a scale
Interval 0.3 to 98.9
30.13 score on a scale
Interval 0.1 to 59.4
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 24
21.05 score on a scale
Interval 0.2 to 59.3
29.93 score on a scale
Interval 0.2 to 93.8
43.55 score on a scale
Interval 8.0 to 90.8
32.41 score on a scale
Interval 0.4 to 98.5
29.06 score on a scale
Interval 0.1 to 57.0
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 26
20.12 score on a scale
Interval 0.0 to 66.5
28.31 score on a scale
Interval 0.2 to 93.0
35.59 score on a scale
Interval 4.3 to 80.6
29.48 score on a scale
Interval 0.3 to 101.9
27.54 score on a scale
Interval 0.3 to 56.5
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 28
20.23 score on a scale
Interval 0.1 to 68.0
27.05 score on a scale
Interval 0.2 to 68.2
32.88 score on a scale
Interval 11.3 to 74.1
29.21 score on a scale
Interval 0.2 to 102.7
27.50 score on a scale
Interval 1.7 to 55.7
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 30
18.05 score on a scale
Interval 0.2 to 59.2
23.79 score on a scale
Interval 0.2 to 58.6
33.63 score on a scale
Interval 10.9 to 76.1
25.75 score on a scale
Interval 0.2 to 79.2
25.40 score on a scale
Interval 0.3 to 50.7
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 32
16.29 score on a scale
Interval 0.0 to 48.0
22.05 score on a scale
Interval 0.1 to 46.4
29.23 score on a scale
Interval 8.8 to 69.8
25.09 score on a scale
Interval 0.2 to 102.2
25.02 score on a scale
Interval 0.2 to 48.3
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 34
15.65 score on a scale
Interval 0.0 to 40.9
22.13 score on a scale
Interval 0.5 to 58.5
27.55 score on a scale
Interval 6.6 to 76.6
24.63 score on a scale
Interval 0.2 to 102.4
25.78 score on a scale
Interval 0.4 to 49.2
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 36
15.46 score on a scale
Interval 0.0 to 39.2
23.78 score on a scale
Interval 0.4 to 51.8
26.86 score on a scale
Interval 10.3 to 73.6
23.82 score on a scale
Interval 0.2 to 93.8
24.13 score on a scale
Interval 0.2 to 56.7
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 40
15.56 score on a scale
Interval 0.1 to 59.3
24.14 score on a scale
Interval 1.1 to 48.0
22.27 score on a scale
Interval 0.3 to 59.8
20.98 score on a scale
Interval 0.1 to 54.3
21.49 score on a scale
Interval 0.4 to 46.6
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 44
11.64 score on a scale
Interval 0.1 to 34.8
20.08 score on a scale
Interval 0.1 to 52.0
17.72 score on a scale
Interval 0.4 to 61.8
18.33 score on a scale
Interval 0.2 to 66.5
21.86 score on a scale
Interval 0.4 to 92.8
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 48
11.90 score on a scale
Interval 0.0 to 40.2
18.54 score on a scale
Interval 0.1 to 39.1
17.54 score on a scale
Interval 0.5 to 62.2
25.83 score on a scale
Interval 0.1 to 67.3
17.78 score on a scale
Interval 0.1 to 45.0
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 52
15.02 score on a scale
Interval 0.0 to 66.3
20.46 score on a scale
Interval 0.1 to 47.4
15.21 score on a scale
Interval 0.2 to 37.3
19.96 score on a scale
Interval 0.3 to 42.5
16.60 score on a scale
Interval 0.0 to 62.6
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 56
11.92 score on a scale
Interval 0.0 to 61.1
19.27 score on a scale
Interval 0.1 to 43.3
16.91 score on a scale
Interval 0.4 to 34.3
20.65 score on a scale
Interval 0.5 to 60.3
18.50 score on a scale
Interval 0.2 to 76.0
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Baseline
68.19 score on a scale
Interval 42.1 to 96.4
68.79 score on a scale
Interval 40.1 to 100.2
66.35 score on a scale
Interval 38.7 to 97.8
68.67 score on a scale
Interval 42.0 to 96.3
69.80 score on a scale
Interval 42.9 to 99.6
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 1
63.06 score on a scale
Interval 28.5 to 97.7
64.99 score on a scale
Interval 22.5 to 99.6
62.83 score on a scale
Interval 26.2 to 94.1
68.40 score on a scale
Interval 29.0 to 97.8
66.53 score on a scale
Interval 34.5 to 95.3
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 2
61.03 score on a scale
Interval 30.8 to 97.1
62.52 score on a scale
Interval 1.8 to 97.1
65.31 score on a scale
Interval 28.1 to 103.7
64.56 score on a scale
Interval 21.3 to 98.7
62.75 score on a scale
Interval 27.1 to 96.8
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 4
54.01 score on a scale
Interval 18.7 to 95.3
57.01 score on a scale
Interval 16.4 to 99.0
65.20 score on a scale
Interval 24.8 to 98.2
60.87 score on a scale
Interval 10.5 to 98.7
59.84 score on a scale
Interval 24.6 to 99.9
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 6
46.32 score on a scale
Interval 8.2 to 82.9
51.34 score on a scale
Interval 11.9 to 93.6
62.07 score on a scale
Interval 19.9 to 99.2
56.59 score on a scale
Interval 0.9 to 101.5
52.39 score on a scale
Interval 10.0 to 88.7
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 8
45.05 score on a scale
Interval 16.8 to 84.5
48.29 score on a scale
Interval 10.2 to 94.4
59.11 score on a scale
Interval 26.0 to 103.4
48.46 score on a scale
Interval 1.0 to 101.4
48.16 score on a scale
Interval 7.5 to 87.6

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 14
-53.03 percentage of score change
Interval -95.4 to 7.4
-42.09 percentage of score change
Interval -98.7 to 16.3
-19.05 percentage of score change
Interval -74.8 to 24.7
-44.39 percentage of score change
Interval -97.3 to 7.9
-41.69 percentage of score change
Interval -83.8 to 18.2
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 15
-55.95 percentage of score change
Interval -99.3 to -7.4
-44.36 percentage of score change
Interval -98.8 to 8.5
-23.19 percentage of score change
Interval -70.1 to 40.4
-48.84 percentage of score change
Interval -98.9 to -0.8
-42.54 percentage of score change
Interval -96.2 to 11.5
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 16
-58.24 percentage of score change
Interval -95.8 to -13.9
-47.00 percentage of score change
Interval -98.5 to 12.1
-23.26 percentage of score change
Interval -71.7 to 42.9
-50.07 percentage of score change
Interval -98.5 to 3.5
-43.47 percentage of score change
Interval -96.7 to 18.9
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 18
-56.06 percentage of score change
Interval -99.5 to -5.0
-48.32 percentage of score change
Interval -91.8 to 79.0
-21.87 percentage of score change
Interval -80.0 to 69.0
-47.48 percentage of score change
Interval -99.2 to 7.1
-46.42 percentage of score change
Interval -97.7 to 20.8
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 1
-7.03 percentage of score change
Interval -58.3 to 36.1
-5.75 percentage of score change
Interval -50.6 to 27.7
-4.54 percentage of score change
Interval -38.8 to 20.3
-1.28 percentage of score change
Interval -35.6 to 50.0
-4.08 percentage of score change
Interval -42.9 to 19.7
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 2
-9.05 percentage of score change
Interval -53.4 to 18.2
-10.37 percentage of score change
Interval -95.9 to 32.8
-0.47 percentage of score change
Interval -34.8 to 45.0
-7.37 percentage of score change
Interval -52.7 to 31.7
-9.14 percentage of score change
Interval -61.8 to 35.2
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 4
-19.60 percentage of score change
Interval -72.2 to 39.5
-15.77 percentage of score change
Interval -79.7 to 40.0
-1.98 percentage of score change
Interval -42.1 to 41.9
-13.51 percentage of score change
Interval -76.4 to 41.0
-12.97 percentage of score change
Interval -54.0 to 36.2
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 6
-30.52 percentage of score change
Interval -73.0 to 15.5
-29.34 percentage of score change
Interval -85.3 to 28.5
-12.34 percentage of score change
Interval -53.5 to 74.8
-19.34 percentage of score change
Interval -98.0 to 45.0
-23.76 percentage of score change
Interval -86.1 to 20.3
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 8
-32.82 percentage of score change
Interval -73.0 to 15.5
-29.34 percentage of score change
Interval -85.3 to 28.5
-12.34 percentage of score change
Interval -53.5 to 74.8
-31.63 percentage of score change
Interval -97.8 to 44.9
-29.29 percentage of score change
Interval -89.6 to 28.1
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 10
-42.53 percentage of score change
Interval -99.1 to -0.5
-34.32 percentage of score change
Interval -86.5 to 4.6
-13.14 percentage of score change
Interval -63.7 to 21.3
-39.55 percentage of score change
Interval -98.7 to 13.7
-34.22 percentage of score change
Interval -89.7 to 28.1
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 12
-49.86 percentage of score change
Interval -95.1 to 0.9
-35.85 percentage of score change
Interval -86.1 to 7.0
-15.56 percentage of score change
Interval -72.6 to 13.8
-41.68 percentage of score change
Interval -97.1 to 11.0
-38.06 percentage of score change
Interval -88.9 to 17.1
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 20
-58.91 percentage of score change
Interval -99.7 to -2.8
-54.95 percentage of score change
Interval -99.7 to 9.6
-27.64 percentage of score change
Interval -85.7 to 76.6
-51.55 percentage of score change
Interval -99.4 to 10.0
-49.39 percentage of score change
Interval -97.9 to 17.8
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 22
-62.02 percentage of score change
Interval -99.7 to -10.4
-58.18 percentage of score change
Interval -99.7 to -0.9
-32.18 percentage of score change
Interval -99.4 to 73.1
-54.91 percentage of score change
Interval -99.4 to 13.3
-55.22 percentage of score change
Interval -99.8 to 26.9
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 24
-68.56 percentage of score change
Interval -99.7 to -3.4
-56.63 percentage of score change
Interval -99.7 to 5.7
-34.10 percentage of score change
Interval -86.3 to 77.0
-53.96 percentage of score change
Interval -99.2 to 13.6
-56.56 percentage of score change
Interval -99.8 to 2.3
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 26
-68.82 percentage of score change
Interval -100.0 to -3.5
-58.19 percentage of score change
Interval -99.7 to 4.8
-47.60 percentage of score change
Interval -92.6 to 18.8
-58.23 percentage of score change
Interval -99.4 to 7.8
-59.24 percentage of score change
Interval -99.5 to -13.5
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 28
-68.19 percentage of score change
Interval -99.8 to -1.3
-59.99 percentage of score change
Interval -99.7 to 8.9
-50.43 percentage of score change
Interval -81.0 to 5.9
-58.86 percentage of score change
Interval -99.6 to 8.7
-58.76 percentage of score change
Interval -97.2 to -12.0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 30
-72.05 percentage of score change
Interval -99.7 to -7.8
-64.57 percentage of score change
Interval -99.7 to -20.2
-49.89 percentage of score change
Interval -76.6 to 14.6
-63.35 percentage of score change
Interval -99.6 to -8.1
-62.81 percentage of score change
Interval -99.5 to -30.2
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 32
-74.40 percentage of score change
Interval -100.0 to -14.9
-67.09 percentage of score change
Interval -99.9 to -27.5
-57.60 percentage of score change
Interval -87.5 to -14.6
-64.78 percentage of score change
Interval -99.6 to 8.1
-62.61 percentage of score change
Interval -99.7 to -24.5
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 34
-75.43 percentage of score change
Interval -100.0 to -31.5
-66.43 percentage of score change
Interval -99.3 to -10.7
-59.75 percentage of score change
Interval -92.3 to 8.7
-64.71 percentage of score change
Interval -99.6 to 8.4
-61.29 percentage of score change
Interval -99.3 to 7.5
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 36
-75.38 percentage of score change
Interval -100.0 to -22.5
-64.60 percentage of score change
Interval -99.5 to -22.9
-60.63 percentage of score change
Interval -87.3 to -1.8
-65.54 percentage of score change
Interval -99.7 to -0.7
-63.75 percentage of score change
Interval -99.6 to 29.5
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 40
-75.95 percentage of score change
Interval -99.8 to -7.6
-64.59 percentage of score change
Interval -98.5 to -30.0
-66.66 percentage of score change
Interval -99.5 to -19.4
-69.85 percentage of score change
Interval -99.8 to -13.5
-66.90 percentage of score change
Interval -99.5 to 6.4
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 44
-80.96 percentage of score change
Interval -99.9 to -31.2
-70.81 percentage of score change
Interval -99.8 to -18.2
-71.50 percentage of score change
Interval -99.4 to 3.2
-74.31 percentage of score change
Interval -99.6 to -3.5
-67.86 percentage of score change
Interval -99.5 to 39.3
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 48
-81.00 percentage of score change
Interval -100.0 to -20.6
-74.06 percentage of score change
Interval -99.9 to -39.9
-71.99 percentage of score change
Interval -99.2 to 3.8
-64.22 percentage of score change
Interval -99.8 to -4.5
-74.60 percentage of score change
Interval -99.8 to -34.0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 52
-77.96 percentage of score change
Interval -100.0 to -12.0
-71.47 percentage of score change
Interval -99.9 to -38.1
-76.93 percentage of score change
Interval -99.6 to -39.9
-70.53 percentage of score change
Interval -99.4 to -23.1
-76.82 percentage of score change
Interval -100.0 to -16.8
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 56
-80.81 percentage of score change
Interval -100.0 to -7.3
-71.83 percentage of score change
Interval -99.9 to -35.2
-74.51 percentage of score change
Interval -99.3 to -39.3
-70.50 percentage of score change
Interval -99.1 to -24.8
-74.01 percentage of score change
Interval -99.7 to 1.1

SECONDARY outcome

Timeframe: 56 Weeks

In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 1
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 2
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 4
0 Participants
3 Participants
1 Participants
1 Participants
1 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 6
1 Participants
2 Participants
0 Participants
2 Participants
2 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 8
2 Participants
2 Participants
0 Participants
5 Participants
2 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 10
6 Participants
2 Participants
1 Participants
6 Participants
4 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 12
12 Participants
4 Participants
1 Participants
9 Participants
6 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 14
11 Participants
4 Participants
2 Participants
8 Participants
5 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 15
9 Participants
8 Participants
2 Participants
10 Participants
7 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 16
16 Participants
10 Participants
1 Participants
10 Participants
8 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 18
16 Participants
12 Participants
1 Participants
10 Participants
8 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 20
15 Participants
14 Participants
3 Participants
13 Participants
9 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 22
18 Participants
14 Participants
3 Participants
13 Participants
12 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 24
20 Participants
12 Participants
3 Participants
14 Participants
10 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 26
25 Participants
18 Participants
4 Participants
13 Participants
14 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 28
23 Participants
14 Participants
3 Participants
11 Participants
12 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 30
22 Participants
17 Participants
4 Participants
13 Participants
12 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 32
24 Participants
23 Participants
5 Participants
14 Participants
13 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 34
24 Participants
20 Participants
7 Participants
16 Participants
11 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 36
27 Participants
19 Participants
8 Participants
18 Participants
14 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 40
19 Participants
13 Participants
7 Participants
10 Participants
17 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 44
25 Participants
16 Participants
11 Participants
12 Participants
16 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 48
20 Participants
18 Participants
9 Participants
8 Participants
21 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 52
18 Participants
15 Participants
10 Participants
10 Participants
19 Participants
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 56
13 Participants
14 Participants
9 Participants
12 Participants
18 Participants

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

The Investigator will calculate the percentage (%) of the total body surface area affected by AD.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 28
-45.8 percentage of total BSA involvement
Interval -87.0 to 3.0
-42.8 percentage of total BSA involvement
Interval -78.0 to 37.0
-29.6 percentage of total BSA involvement
Interval -70.0 to 7.0
-41.2 percentage of total BSA involvement
Interval -90.0 to 34.0
-43.1 percentage of total BSA involvement
Interval -83.0 to -5.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 1
-0.4 percentage of total BSA involvement
Interval -35.0 to 40.0
-0.1 percentage of total BSA involvement
Interval -23.0 to 23.0
-1.2 percentage of total BSA involvement
Interval -35.0 to 45.0
-0.5 percentage of total BSA involvement
Interval -25.0 to 17.0
-1.4 percentage of total BSA involvement
Interval -25.0 to 23.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 2
-6.4 percentage of total BSA involvement
Interval -45.0 to 25.0
-1.9 percentage of total BSA involvement
Interval -24.0 to 38.0
0.1 percentage of total BSA involvement
Interval -38.0 to 50.0
-2.6 percentage of total BSA involvement
Interval -42.0 to 20.0
-3.8 percentage of total BSA involvement
Interval -48.0 to 15.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 4
-10.7 percentage of total BSA involvement
Interval -63.0 to 25.0
-5.6 percentage of total BSA involvement
Interval -49.0 to 23.0
-2.2 percentage of total BSA involvement
Interval -27.0 to 20.0
-6.7 percentage of total BSA involvement
Interval -60.0 to 35.0
-4.0 percentage of total BSA involvement
Interval -48.0 to 39.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 6
-16.9 percentage of total BSA involvement
Interval -68.0 to 25.0
-12.1 percentage of total BSA involvement
Interval -55.0 to 42.0
-4.0 percentage of total BSA involvement
Interval -35.0 to 20.0
-13.7 percentage of total BSA involvement
Interval -60.0 to 30.0
-11.2 percentage of total BSA involvement
Interval -63.0 to 22.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 8
-21.4 percentage of total BSA involvement
Interval -73.0 to 25.0
-17.2 percentage of total BSA involvement
Interval -55.0 to 25.0
-4.4 percentage of total BSA involvement
Interval -33.0 to 40.0
-18.6 percentage of total BSA involvement
Interval -70.0 to 32.0
-19.3 percentage of total BSA involvement
Interval -76.0 to 6.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 10
-26.0 percentage of total BSA involvement
Interval -73.0 to 25.0
-20.7 percentage of total BSA involvement
Interval -65.0 to 19.0
-4.8 percentage of total BSA involvement
Interval -35.0 to 20.0
-24.5 percentage of total BSA involvement
Interval -71.0 to 39.0
-22.6 percentage of total BSA involvement
Interval -68.0 to 3.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 12
-31.1 percentage of total BSA involvement
Interval -77.0 to 25.0
-22.2 percentage of total BSA involvement
Interval -72.0 to 22.0
-4.9 percentage of total BSA involvement
Interval -35.0 to 20.0
-27.4 percentage of total BSA involvement
Interval -75.0 to 39.0
-26.4 percentage of total BSA involvement
Interval -73.0 to 5.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 14
-33.6 percentage of total BSA involvement
Interval -77.0 to 28.0
-24.4 percentage of total BSA involvement
Interval -75.0 to 22.0
-10.2 percentage of total BSA involvement
Interval -61.0 to 13.0
-29.8 percentage of total BSA involvement
Interval -75.0 to 35.0
-29.4 percentage of total BSA involvement
Interval -88.0 to 3.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 15
-35.1 percentage of total BSA involvement
Interval -81.0 to 15.0
-25.6 percentage of total BSA involvement
Interval -75.0 to 32.0
-12.2 percentage of total BSA involvement
Interval -61.0 to 20.0
-31.9 percentage of total BSA involvement
Interval -75.0 to 24.0
-29.3 percentage of total BSA involvement
Interval -79.0 to 2.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 16
-35.5 percentage of total BSA involvement
Interval -78.0 to 20.0
-28.9 percentage of total BSA involvement
Interval -80.0 to 24.0
-14.1 percentage of total BSA involvement
Interval -60.0 to 20.0
-31.9 percentage of total BSA involvement
Interval -75.0 to 39.0
-29.6 percentage of total BSA involvement
Interval -89.0 to 25.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 18
-35.5 percentage of total BSA involvement
Interval -75.0 to 5.0
-29.6 percentage of total BSA involvement
Interval -86.0 to 39.0
-13.1 percentage of total BSA involvement
Interval -60.0 to 30.0
-34.6 percentage of total BSA involvement
Interval -80.0 to 39.0
-32.7 percentage of total BSA involvement
Interval -89.0 to 0.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 20
-39.7 percentage of total BSA involvement
Interval -70.0 to 7.0
-34.6 percentage of total BSA involvement
Interval -86.0 to 19.0
-13.3 percentage of total BSA involvement
Interval -70.0 to 35.0
-35.9 percentage of total BSA involvement
Interval -90.0 to 39.0
-34.8 percentage of total BSA involvement
Interval -84.0 to 2.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 22
-40.6 percentage of total BSA involvement
Interval -77.0 to 11.0
-38.3 percentage of total BSA involvement
Interval -80.0 to 21.0
-18.5 percentage of total BSA involvement
Interval -95.0 to 35.0
-39.3 percentage of total BSA involvement
Interval -94.0 to 39.0
-38.3 percentage of total BSA involvement
Interval -84.0 to 0.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 24
-42.9 percentage of total BSA involvement
Interval -75.0 to 20.0
-40.6 percentage of total BSA involvement
Interval -80.0 to 10.0
-21.1 percentage of total BSA involvement
Interval -75.0 to 37.0
-37.7 percentage of total BSA involvement
Interval -91.0 to 39.0
-39.0 percentage of total BSA involvement
Interval -79.0 to 0.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 26
-46.4 percentage of total BSA involvement
Interval -88.0 to -10.0
-42.0 percentage of total BSA involvement
Interval -82.0 to 27.0
-26.9 percentage of total BSA involvement
Interval -80.0 to 9.0
-38.3 percentage of total BSA involvement
Interval -85.0 to 39.0
-42.1 percentage of total BSA involvement
Interval -81.0 to -5.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 30
-46.2 percentage of total BSA involvement
Interval -87.0 to -5.0
-47.2 percentage of total BSA involvement
Interval -80.0 to -8.0
-32.1 percentage of total BSA involvement
Interval -70.0 to 6.0
-41.4 percentage of total BSA involvement
Interval -93.0 to 19.0
-45.5 percentage of total BSA involvement
Interval -89.0 to -10.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 32
-48.3 percentage of total BSA involvement
Interval -85.0 to -15.0
-48.2 percentage of total BSA involvement
Interval -84.0 to -3.0
-39.6 percentage of total BSA involvement
Interval -80.0 to -9.0
-44.0 percentage of total BSA involvement
Interval -90.0 to 39.0
-46.5 percentage of total BSA involvement
Interval -89.0 to -7.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 34
-50.7 percentage of total BSA involvement
Interval -90.0 to -18.0
-49.0 percentage of total BSA involvement
Interval -80.0 to -3.0
-41.2 percentage of total BSA involvement
Interval -85.0 to -3.0
-44.4 percentage of total BSA involvement
Interval -92.0 to 39.0
-45.1 percentage of total BSA involvement
Interval -94.0 to -2.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 36
-50.3 percentage of total BSA involvement
Interval -92.0 to -17.0
-48.0 percentage of total BSA involvement
Interval -84.0 to -3.0
-40.8 percentage of total BSA involvement
Interval -95.0 to 4.0
-44.6 percentage of total BSA involvement
Interval -93.0 to 39.0
-48.1 percentage of total BSA involvement
Interval -89.0 to 4.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 40
-51.6 percentage of total BSA involvement
Interval -92.0 to -18.0
-51.1 percentage of total BSA involvement
Interval -82.0 to -4.0
-46.6 percentage of total BSA involvement
Interval -99.0 to -1.0
-49.0 percentage of total BSA involvement
Interval -95.0 to -5.0
-50.6 percentage of total BSA involvement
Interval -87.0 to -4.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 44
-53.5 percentage of total BSA involvement
Interval -90.0 to -18.0
-50.8 percentage of total BSA involvement
Interval -90.0 to 4.0
-47.5 percentage of total BSA involvement
Interval -89.0 to -10.0
-50.8 percentage of total BSA involvement
Interval -95.0 to -13.0
-47.9 percentage of total BSA involvement
Interval -88.0 to 5.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 48
-53.9 percentage of total BSA involvement
Interval -90.0 to -18.0
-53.7 percentage of total BSA involvement
Interval -90.0 to -24.0
-46.2 percentage of total BSA involvement
Interval -90.0 to 0.0
-46.6 percentage of total BSA involvement
Interval -87.0 to -12.0
-52.7 percentage of total BSA involvement
Interval -89.0 to -13.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 52
-53.7 percentage of total BSA involvement
Interval -90.0 to -18.0
-55.8 percentage of total BSA involvement
Interval -90.0 to -24.0
-48.6 percentage of total BSA involvement
Interval -90.0 to -9.0
-49.7 percentage of total BSA involvement
Interval -87.0 to -20.0
-51.9 percentage of total BSA involvement
Interval -89.0 to -12.0
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 56
-53.8 percentage of total BSA involvement
Interval -90.0 to -18.0
-58.6 percentage of total BSA involvement
Interval -90.0 to -27.0
-45.9 percentage of total BSA involvement
Interval -85.0 to -6.0
-45.6 percentage of total BSA involvement
Interval -80.0 to -10.0
-47.2 percentage of total BSA involvement
Interval -89.0 to 3.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 52
1.9 score on a scale
Interval 0.0 to 10.0
2.9 score on a scale
Interval 0.0 to 10.0
1.4 score on a scale
Interval 0.0 to 4.0
2.8 score on a scale
Interval 0.0 to 9.0
2.0 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 56
1.9 score on a scale
Interval 0.0 to 10.0
2.4 score on a scale
Interval 0.0 to 10.0
1.3 score on a scale
Interval 0.0 to 3.0
2.8 score on a scale
Interval 0.0 to 9.0
2.3 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Baseline
7.3 score on a scale
Interval 3.0 to 10.0
7.6 score on a scale
Interval 1.0 to 10.0
7.2 score on a scale
Interval 1.0 to 10.0
7.7 score on a scale
Interval 3.0 to 10.0
7.7 score on a scale
Interval 2.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 1
6.8 score on a scale
Interval 1.0 to 10.0
6.8 score on a scale
Interval 1.0 to 10.0
6.9 score on a scale
Interval 1.0 to 10.0
7.3 score on a scale
Interval 2.0 to 10.0
7.3 score on a scale
Interval 2.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 2
6.3 score on a scale
Interval 2.0 to 10.0
6.8 score on a scale
Interval 1.0 to 10.0
7.1 score on a scale
Interval 2.0 to 10.0
6.8 score on a scale
Interval 2.0 to 10.0
7.0 score on a scale
Interval 2.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 4
5.7 score on a scale
Interval 0.0 to 10.0
6.2 score on a scale
Interval 1.0 to 10.0
7.1 score on a scale
Interval 3.0 to 10.0
6.4 score on a scale
Interval 1.0 to 10.0
6.2 score on a scale
Interval 1.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 6
4.7 score on a scale
Interval 0.0 to 10.0
5.5 score on a scale
Interval 0.0 to 10.0
6.5 score on a scale
Interval 1.0 to 10.0
6.0 score on a scale
Interval 1.0 to 10.0
5.4 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 8
4.4 score on a scale
Interval 0.0 to 9.0
5.2 score on a scale
Interval 1.0 to 10.0
6.0 score on a scale
Interval 1.0 to 10.0
5.4 score on a scale
Interval 1.0 to 10.0
5.2 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 10
4.0 score on a scale
Interval 0.0 to 9.0
5.1 score on a scale
Interval 1.0 to 10.0
5.8 score on a scale
Interval 1.0 to 10.0
4.9 score on a scale
Interval 1.0 to 9.0
4.7 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 12
3.6 score on a scale
Interval 0.0 to 10.0
4.7 score on a scale
Interval 1.0 to 10.0
5.8 score on a scale
Interval 1.0 to 10.0
4.8 score on a scale
Interval 0.0 to 9.0
4.2 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 14
3.3 score on a scale
Interval 0.0 to 9.0
4.6 score on a scale
Interval 1.0 to 10.0
5.9 score on a scale
Interval 1.0 to 10.0
4.5 score on a scale
Interval 1.0 to 9.0
3.7 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 15
2.9 score on a scale
Interval 0.0 to 9.0
4.2 score on a scale
Interval 1.0 to 9.0
5.3 score on a scale
Interval 1.0 to 10.0
4.4 score on a scale
Interval 1.0 to 9.0
3.8 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 16
2.8 score on a scale
Interval 0.0 to 9.0
4.1 score on a scale
Interval 0.0 to 9.0
5.2 score on a scale
Interval 0.0 to 10.0
4.6 score on a scale
Interval 1.0 to 9.0
3.6 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 18
3.3 score on a scale
Interval 0.0 to 8.0
4.2 score on a scale
Interval 0.0 to 10.0
5.2 score on a scale
Interval 0.0 to 9.0
4.2 score on a scale
Interval 1.0 to 9.0
3.7 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 20
2.9 score on a scale
Interval 0.0 to 8.0
3.7 score on a scale
Interval 0.0 to 10.0
4.8 score on a scale
Interval 0.0 to 9.0
4.0 score on a scale
Interval 1.0 to 10.0
3.2 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 22
2.3 score on a scale
Interval 0.0 to 7.0
3.5 score on a scale
Interval 0.0 to 10.0
4.8 score on a scale
Interval 1.0 to 9.0
4.0 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 24
2.2 score on a scale
Interval 0.0 to 8.0
3.6 score on a scale
Interval 0.0 to 9.0
4.3 score on a scale
Interval 0.0 to 9.0
4.0 score on a scale
Interval 0.0 to 9.0
3.2 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 26
2.0 score on a scale
Interval 0.0 to 9.0
3.3 score on a scale
Interval 0.0 to 9.0
4.1 score on a scale
Interval 0.0 to 9.0
3.7 score on a scale
Interval 0.0 to 9.0
3.0 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 28
1.8 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 8.0
3.5 score on a scale
Interval 0.0 to 8.0
3.7 score on a scale
Interval 0.0 to 10.0
3.1 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 30
2.1 score on a scale
Interval 0.0 to 9.0
2.9 score on a scale
Interval 0.0 to 9.0
3.5 score on a scale
Interval 0.0 to 9.0
3.3 score on a scale
Interval 0.0 to 9.0
2.5 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 32
2.0 score on a scale
Interval 0.0 to 9.0
2.7 score on a scale
Interval 0.0 to 7.0
2.9 score on a scale
Interval 0.0 to 8.0
3.2 score on a scale
Interval 0.0 to 9.0
2.7 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 34
1.9 score on a scale
Interval 0.0 to 7.0
3.0 score on a scale
Interval 0.0 to 8.0
2.7 score on a scale
Interval 0.0 to 8.0
3.1 score on a scale
Interval 0.0 to 9.0
2.8 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 36
1.8 score on a scale
Interval 0.0 to 8.0
2.8 score on a scale
Interval 0.0 to 8.0
2.6 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 8.0
2.5 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 40
2.1 score on a scale
Interval 0.0 to 10.0
2.8 score on a scale
Interval 0.0 to 8.0
2.4 score on a scale
Interval 0.0 to 7.0
2.8 score on a scale
Interval 0.0 to 8.0
2.9 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 44
1.6 score on a scale
Interval 0.0 to 6.0
2.3 score on a scale
Interval 0.0 to 8.0
1.6 score on a scale
Interval 0.0 to 5.0
2.9 score on a scale
Interval 0.0 to 7.0
2.4 score on a scale
Interval 0.0 to 10.0
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 48
1.7 score on a scale
Interval 0.0 to 7.0
2.2 score on a scale
Interval 0.0 to 6.0
1.8 score on a scale
Interval 0.0 to 9.0
3.2 score on a scale
Interval 0.0 to 9.0
2.2 score on a scale
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 4
-18.8 percentage of score change
Interval -100.0 to 133.0
-17.3 percentage of score change
Interval -89.0 to 43.0
14.0 percentage of score change
Interval -63.0 to 350.0
-16.8 percentage of score change
Interval -80.0 to 80.0
-8.3 percentage of score change
Interval -80.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 6
-32.5 percentage of score change
Interval -100.0 to 25.0
-26.0 percentage of score change
Interval -100.0 to 100.0
5.2 percentage of score change
Interval -71.0 to 300.0
-22.1 percentage of score change
Interval -90.0 to 80.0
-26.0 percentage of score change
Interval -100.0 to 75.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 1
-3.4 percentage of score change
Interval -88.0 to 100.0
-12.2 percentage of score change
Interval -50.0 to 33.0
2.6 percentage of score change
Interval -67.0 to 300.0
-2.9 percentage of score change
Interval -60.0 to 167.0
2.5 percentage of score change
Interval -56.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 2
-11.9 percentage of score change
Interval -78.0 to 50.0
-11.8 percentage of score change
Interval -89.0 to 43.0
12.9 percentage of score change
Interval -75.0 to 300.0
-12.2 percentage of score change
Interval -63.0 to 67.0
-1.7 percentage of score change
Interval -50.0 to 200.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 8
-37.3 percentage of score change
Interval -100.0 to 50.0
-31.0 percentage of score change
Interval -89.0 to 33.0
-8.8 percentage of score change
Interval -88.0 to 200.0
-28.1 percentage of score change
Interval -90.0 to 60.0
-25.5 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 10
-43.5 percentage of score change
Interval -100.0 to 50.0
-32.1 percentage of score change
Interval -88.0 to 50.0
-14.3 percentage of score change
Interval -89.0 to 200.0
-37.0 percentage of score change
Interval -90.0 to 20.0
-36.9 percentage of score change
Interval -100.0 to 75.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 12
-49.0 percentage of score change
Interval -100.0 to 33.0
-36.0 percentage of score change
Interval -90.0 to 40.0
-16.0 percentage of score change
Interval -89.0 to 100.0
-37.9 percentage of score change
Interval -100.0 to 29.0
-37.9 percentage of score change
Interval -100.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 14
-52.7 percentage of score change
Interval -100.0 to 50.0
-36.0 percentage of score change
Interval -90.0 to 100.0
-13.5 percentage of score change
Interval -88.0 to 200.0
-43.9 percentage of score change
Interval -90.0 to 0.0
-45.1 percentage of score change
Interval -100.0 to 100.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 15
-57.8 percentage of score change
Interval -100.0 to 25.0
-42.6 percentage of score change
Interval -90.0 to 20.0
-16.3 percentage of score change
Interval -89.0 to 300.0
-41.7 percentage of score change
Interval -90.0 to 29.0
-43.6 percentage of score change
Interval -100.0 to 150.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 16
-57.4 percentage of score change
Interval -100.0 to 50.0
-45.7 percentage of score change
Interval -100.0 to 20.0
-20.4 percentage of score change
Interval -100.0 to 200.0
-39.9 percentage of score change
Interval -90.0 to 29.0
-44.1 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 18
-52.1 percentage of score change
Interval -100.0 to 25.0
-42.9 percentage of score change
Interval -100.0 to 100.0
-29.3 percentage of score change
Interval -100.0 to 60.0
-45.8 percentage of score change
Interval -89.0 to 13.0
-44.5 percentage of score change
Interval -100.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 20
-56.5 percentage of score change
Interval -100.0 to 50.0
-49.7 percentage of score change
Interval -100.0 to 33.0
-25.1 percentage of score change
Interval -100.0 to 200.0
-46.6 percentage of score change
Interval -90.0 to 50.0
-49.2 percentage of score change
Interval -100.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 22
-66.2 percentage of score change
Interval -100.0 to 25.0
-53.6 percentage of score change
Interval -100.0 to 11.0
-20.9 percentage of score change
Interval -90.0 to 300.0
-48.0 percentage of score change
Interval -100.0 to 13.0
-52.1 percentage of score change
Interval -100.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 24
-66.7 percentage of score change
Interval -100.0 to 0.0
-51.4 percentage of score change
Interval -100.0 to 13.0
-33.7 percentage of score change
Interval -100.0 to 100.0
-48.9 percentage of score change
Interval -100.0 to 14.0
-53.3 percentage of score change
Interval -100.0 to 75.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 26
-71.2 percentage of score change
Interval -100.0 to 0.0
-54.0 percentage of score change
Interval -100.0 to 30.0
-39.3 percentage of score change
Interval -100.0 to 40.0
-52.4 percentage of score change
Interval -100.0 to 13.0
-52.2 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 28
-73.7 percentage of score change
Interval -100.0 to 25.0
-57.1 percentage of score change
Interval -100.0 to 0.0
-45.4 percentage of score change
Interval -100.0 to 20.0
-50.3 percentage of score change
Interval -100.0 to 40.0
-56.2 percentage of score change
Interval -100.0 to 11.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 30
-69.4 percentage of score change
Interval -100.0 to 75.0
-60.0 percentage of score change
Interval -100.0 to 20.0
-48.4 percentage of score change
Interval -100.0 to 80.0
-56.1 percentage of score change
Interval -100.0 to 14.0
-64.3 percentage of score change
Interval -100.0 to 11.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 32
-70.5 percentage of score change
Interval -100.0 to 25.0
-60.9 percentage of score change
Interval -100.0 to 20.0
-63.6 percentage of score change
Interval -100.0 to 0.0
-58.3 percentage of score change
Interval -100.0 to 13.0
-61.4 percentage of score change
Interval -100.0 to 11.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 34
-72.8 percentage of score change
Interval -100.0 to 25.0
-57.5 percentage of score change
Interval -100.0 to 40.0
-63.1 percentage of score change
Interval -100.0 to 40.0
-60.9 percentage of score change
Interval -100.0 to 13.0
-58.1 percentage of score change
Interval -100.0 to 50.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 36
-72.3 percentage of score change
Interval -100.0 to 25.0
-60.5 percentage of score change
Interval -100.0 to 60.0
-64.0 percentage of score change
Interval -100.0 to 13.0
-59.7 percentage of score change
Interval -100.0 to 0.0
-60.9 percentage of score change
Interval -100.0 to 150.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 40
-70.2 percentage of score change
Interval -100.0 to 25.0
-60.7 percentage of score change
Interval -100.0 to 0.0
-67.0 percentage of score change
Interval -100.0 to 0.0
-61.7 percentage of score change
Interval -100.0 to 0.0
-52.8 percentage of score change
Interval -100.0 to 250.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 44
-77.1 percentage of score change
Interval -100.0 to -25.0
-68.4 percentage of score change
Interval -100.0 to 0.0
-75.2 percentage of score change
Interval -100.0 to -29.0
-59.2 percentage of score change
Interval -100.0 to 0.0
-70.6 percentage of score change
Interval -100.0 to 11.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 48
-74.0 percentage of score change
Interval -100.0 to 0.0
-68.3 percentage of score change
Interval -100.0 to 0.0
-69.7 percentage of score change
Interval -100.0 to 80.0
-56.7 percentage of score change
Interval -100.0 to -10.0
-69.3 percentage of score change
Interval -100.0 to 11.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 52
-72.9 percentage of score change
Interval -100.0 to 43.0
-60.3 percentage of score change
Interval -100.0 to 11.0
-80.3 percentage of score change
Interval -100.0 to 33.0
-57.1 percentage of score change
Interval -100.0 to 50.0
-70.1 percentage of score change
Interval -100.0 to 50.0
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 56
-75.7 percentage of score change
Interval -100.0 to 0.0
-65.6 percentage of score change
Interval -100.0 to 11.0
-82.1 percentage of score change
Interval -100.0 to -50.0
-60.2 percentage of score change
Interval -100.0 to 0.0
-67.2 percentage of score change
Interval -100.0 to 14.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Baseline
5.0 score on a scale
Interval 0.0 to 10.0
5.9 score on a scale
Interval 0.0 to 10.0
5.0 score on a scale
Interval 0.0 to 10.0
5.9 score on a scale
Interval 0.0 to 10.0
5.5 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 1
5.2 score on a scale
Interval 0.0 to 10.0
5.1 score on a scale
Interval 0.0 to 10.0
5.1 score on a scale
Interval 0.0 to 10.0
6.0 score on a scale
Interval 1.0 to 10.0
5.4 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 2
4.7 score on a scale
Interval 0.0 to 10.0
5.5 score on a scale
Interval 0.0 to 10.0
5.6 score on a scale
Interval 0.0 to 10.0
5.3 score on a scale
Interval 1.0 to 10.0
5.1 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 4
4.3 score on a scale
Interval 0.0 to 10.0
5.0 score on a scale
Interval 0.0 to 10.0
5.6 score on a scale
Interval 0.0 to 10.0
5.5 score on a scale
Interval 0.0 to 10.0
4.7 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 6
3.2 score on a scale
Interval 0.0 to 9.0
4.3 score on a scale
Interval 0.0 to 9.0
5.0 score on a scale
Interval 0.0 to 9.0
5.3 score on a scale
Interval 0.0 to 10.0
3.8 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 8
3.0 score on a scale
Interval 0.0 to 9.0
4.2 score on a scale
Interval 0.0 to 10.0
4.8 score on a scale
Interval 0.0 to 10.0
4.5 score on a scale
Interval 0.0 to 10.0
3.5 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 10
2.5 score on a scale
Interval 0.0 to 8.0
3.9 score on a scale
Interval 0.0 to 9.0
4.6 score on a scale
Interval 0.0 to 10.0
3.9 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 10.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 12
2.1 score on a scale
Interval 0.0 to 9.0
3.6 score on a scale
Interval 0.0 to 10.0
4.4 score on a scale
Interval 0.0 to 9.0
3.5 score on a scale
Interval 0.0 to 10.0
3.2 score on a scale
Interval 0.0 to 9.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 14
2.5 score on a scale
Interval 0.0 to 8.0
3.3 score on a scale
Interval 0.0 to 10.0
4.7 score on a scale
Interval 0.0 to 10.0
3.8 score on a scale
Interval 0.0 to 9.0
2.5 score on a scale
Interval 0.0 to 9.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 15
1.9 score on a scale
Interval 0.0 to 8.0
3.0 score on a scale
Interval 0.0 to 7.0
4.6 score on a scale
Interval 0.0 to 9.0
3.4 score on a scale
Interval 0.0 to 9.0
2.7 score on a scale
Interval 0.0 to 9.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 16
1.8 score on a scale
Interval 0.0 to 7.0
2.9 score on a scale
Interval 0.0 to 8.0
4.2 score on a scale
Interval 0.0 to 10.0
3.5 score on a scale
Interval 0.0 to 10.0
2.7 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 18
1.6 score on a scale
Interval 0.0 to 6.0
3.2 score on a scale
Interval 0.0 to 10.0
4.2 score on a scale
Interval 0.0 to 9.0
3.6 score on a scale
Interval 0.0 to 9.0
2.3 score on a scale
Interval 0.0 to 9.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 20
1.6 score on a scale
Interval 0.0 to 7.0
2.9 score on a scale
Interval 0.0 to 10.0
4.0 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 10.0
2.1 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 22
1.3 score on a scale
Interval 0.0 to 6.0
2.7 score on a scale
Interval 0.0 to 10.0
3.8 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 9.0
2.3 score on a scale
Interval 0.0 to 9.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 24
1.5 score on a scale
Interval 0.0 to 9.0
2.7 score on a scale
Interval 0.0 to 8.0
3.5 score on a scale
Interval 0.0 to 9.0
2.9 score on a scale
Interval 0.0 to 9.0
2.1 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 26
1.2 score on a scale
Interval 0.0 to 5.0
2.4 score on a scale
Interval 0.0 to 8.0
3.2 score on a scale
Interval 0.0 to 9.0
3.1 score on a scale
Interval 0.0 to 9.0
1.7 score on a scale
Interval 0.0 to 7.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 28
1.1 score on a scale
Interval 0.0 to 7.0
2.3 score on a scale
Interval 0.0 to 8.0
2.7 score on a scale
Interval 0.0 to 8.0
3.1 score on a scale
Interval 0.0 to 10.0
1.6 score on a scale
Interval 0.0 to 7.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 30
1.1 score on a scale
Interval 0.0 to 6.0
1.9 score on a scale
Interval 0.0 to 9.0
2.6 score on a scale
Interval 0.0 to 9.0
2.5 score on a scale
Interval 0.0 to 9.0
1.4 score on a scale
Interval 0.0 to 7.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 32
1.2 score on a scale
Interval 0.0 to 5.0
1.9 score on a scale
Interval 0.0 to 8.0
2.4 score on a scale
Interval 0.0 to 8.0
2.3 score on a scale
Interval 0.0 to 9.0
1.9 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 34
0.9 score on a scale
Interval 0.0 to 6.0
2.1 score on a scale
Interval 0.0 to 7.0
2.1 score on a scale
Interval 0.0 to 8.0
2.3 score on a scale
Interval 0.0 to 9.0
1.5 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 36
0.9 score on a scale
Interval 0.0 to 6.0
2.1 score on a scale
Interval 0.0 to 8.0
2.0 score on a scale
Interval 0.0 to 9.0
2.0 score on a scale
Interval 0.0 to 9.0
1.6 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 40
0.8 score on a scale
Interval 0.0 to 4.0
1.9 score on a scale
Interval 0.0 to 7.0
2.0 score on a scale
Interval 0.0 to 8.0
1.5 score on a scale
Interval 0.0 to 8.0
1.5 score on a scale
Interval 0.0 to 7.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 44
0.6 score on a scale
Interval 0.0 to 4.0
1.4 score on a scale
Interval 0.0 to 8.0
1.1 score on a scale
Interval 0.0 to 4.0
1.9 score on a scale
Interval 0.0 to 7.0
1.4 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 48
0.6 score on a scale
Interval 0.0 to 4.0
1.3 score on a scale
Interval 0.0 to 5.0
0.9 score on a scale
Interval 0.0 to 2.0
2.1 score on a scale
Interval 0.0 to 9.0
1.2 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 52
1.3 score on a scale
Interval 0.0 to 9.0
1.9 score on a scale
Interval 0.0 to 6.0
1.2 score on a scale
Interval 0.0 to 3.0
1.6 score on a scale
Interval 0.0 to 7.0
0.8 score on a scale
Interval 0.0 to 8.0
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 56
1.1 score on a scale
Interval 0.0 to 9.0
1.5 score on a scale
Interval 0.0 to 8.0
0.9 score on a scale
Interval 0.0 to 2.0
2.1 score on a scale
Interval 0.0 to 9.0
1.1 score on a scale
Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 1
29.8 percentage of score change
Interval -100.0 to 400.0
-15.7 percentage of score change
Interval -100.0 to 80.0
51.3 percentage of score change
Interval -100.0 to 700.0
6.6 percentage of score change
Interval -83.0 to 300.0
14.2 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 2
12.0 percentage of score change
Interval -100.0 to 350.0
-6.7 percentage of score change
Interval -100.0 to 167.0
60.3 percentage of score change
Interval -100.0 to 700.0
-0.7 percentage of score change
Interval -90.0 to 350.0
12.6 percentage of score change
Interval -100.0 to 600.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 4
11.9 percentage of score change
Interval -100.0 to 600.0
-11.2 percentage of score change
Interval -100.0 to 167.0
49.6 percentage of score change
Interval -100.0 to 600.0
4.9 percentage of score change
Interval -100.0 to 400.0
12.1 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 6
-18.3 percentage of score change
Interval -100.0 to 400.0
-25.5 percentage of score change
Interval -100.0 to 167.0
33.6 percentage of score change
Interval -100.0 to 500.0
6.2 percentage of score change
Interval -100.0 to 400.0
-7.1 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 8
-27.3 percentage of score change
Interval -100.0 to 400.0
-31.8 percentage of score change
Interval -100.0 to 43.0
13.5 percentage of score change
Interval -100.0 to 500.0
-11.7 percentage of score change
Interval -100.0 to 300.0
-10.8 percentage of score change
Interval -100.0 to 400.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 10
-41.3 percentage of score change
Interval -100.0 to 200.0
-36.1 percentage of score change
Interval -100.0 to 60.0
11.7 percentage of score change
Interval -100.0 to 500.0
-29.8 percentage of score change
Interval -100.0 to 300.0
-31.9 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 12
-54.8 percentage of score change
Interval -100.0 to 17.0
-38.9 percentage of score change
Interval -100.0 to 33.0
4.5 percentage of score change
Interval -100.0 to 500.0
-37.1 percentage of score change
Interval -100.0 to 200.0
-13.4 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 14
-49.6 percentage of score change
Interval -100.0 to 50.0
-44.0 percentage of score change
Interval -100.0 to 40.0
14.5 percentage of score change
Interval -100.0 to 600.0
-34.5 percentage of score change
Interval -100.0 to 200.0
-38.4 percentage of score change
Interval -100.0 to 400.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 15
-60.9 percentage of score change
Interval -100.0 to 100.0
-46.6 percentage of score change
Interval -100.0 to 25.0
13.7 percentage of score change
Interval -100.0 to 500.0
-41.9 percentage of score change
Interval -100.0 to 100.0
-28.1 percentage of score change
Interval -100.0 to 300.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 16
-63.4 percentage of score change
Interval -100.0 to 67.0
-48.5 percentage of score change
Interval -100.0 to 50.0
0.7 percentage of score change
Interval -100.0 to 600.0
-38.4 percentage of score change
Interval -100.0 to 100.0
-10.9 percentage of score change
Interval -100.0 to 600.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 18
-66.9 percentage of score change
Interval -100.0 to 25.0
-38.9 percentage of score change
Interval -100.0 to 300.0
8.1 percentage of score change
Interval -100.0 to 700.0
-42.2 percentage of score change
Interval -100.0 to 50.0
-48.7 percentage of score change
Interval -100.0 to 300.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 20
-72.3 percentage of score change
Interval -100.0 to 25.0
-50.0 percentage of score change
Interval -100.0 to 50.0
9.1 percentage of score change
Interval -100.0 to 800.0
-44.4 percentage of score change
Interval -100.0 to 100.0
-48.4 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 22
-75.1 percentage of score change
Interval -100.0 to 25.0
-56.1 percentage of score change
Interval -100.0 to 29.0
-2.3 percentage of score change
Interval -100.0 to 700.0
-45.0 percentage of score change
Interval -100.0 to 200.0
-45.1 percentage of score change
Interval -100.0 to 500.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 24
-67.3 percentage of score change
Interval -100.0 to 200.0
-52.5 percentage of score change
Interval -100.0 to 60.0
-5.5 percentage of score change
Interval -100.0 to 600.0
-53.1 percentage of score change
Interval -100.0 to 50.0
-53.3 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 26
-75.5 percentage of score change
Interval -100.0 to 0.0
-57.1 percentage of score change
Interval -100.0 to 60.0
-39.4 percentage of score change
Interval -100.0 to 80.0
-46.5 percentage of score change
Interval -100.0 to 100.0
-55.5 percentage of score change
Interval -100.0 to 300.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 28
-80.4 percentage of score change
Interval -100.0 to 50.0
-58.8 percentage of score change
Interval -100.0 to 33.0
-38.9 percentage of score change
Interval -100.0 to 60.0
-48.7 percentage of score change
Interval -100.0 to 100.0
-54.4 percentage of score change
Interval -100.0 to 200.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 30
-77.4 percentage of score change
Interval -100.0 to 67.0
-67.1 percentage of score change
Interval -100.0 to 40.0
-45.6 percentage of score change
Interval -100.0 to 80.0
-58.1 percentage of score change
Interval -100.0 to 29.0
-63.3 percentage of score change
Interval -100.0 to 300.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 32
-78.0 percentage of score change
Interval -100.0 to 25.0
-65.8 percentage of score change
Interval -100.0 to 0.0
-55.3 percentage of score change
Interval -100.0 to 40.0
-60.0 percentage of score change
Interval -100.0 to 0.0
-45.6 percentage of score change
Interval -100.0 to 700.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 34
-82.5 percentage of score change
Interval -100.0 to 0.0
-64.8 percentage of score change
Interval -100.0 to 20.0
-51.7 percentage of score change
Interval -100.0 to 33.0
-61.1 percentage of score change
Interval -100.0 to 0.0
-66.0 percentage of score change
Interval -100.0 to 100.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 36
-81.9 percentage of score change
Interval -100.0 to -25.0
-64.7 percentage of score change
Interval -100.0 to 20.0
-56.2 percentage of score change
Interval -100.0 to 20.0
-64.9 percentage of score change
Interval -100.0 to 17.0
-45.1 percentage of score change
Interval -100.0 to 700.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 40
-81.0 percentage of score change
Interval -100.0 to 0.0
-67.8 percentage of score change
Interval -100.0 to 0.0
-57.2 percentage of score change
Interval -100.0 to 60.0
-71.6 percentage of score change
Interval -100.0 to 0.0
-50.7 percentage of score change
Interval -100.0 to 400.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 44
-88.5 percentage of score change
Interval -100.0 to 0.0
-79.6 percentage of score change
Interval -100.0 to -14.0
-65.3 percentage of score change
Interval -100.0 to 0.0
-65.7 percentage of score change
Interval -100.0 to 25.0
-71.4 percentage of score change
Interval -100.0 to 100.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 48
-84.9 percentage of score change
Interval -100.0 to 33.0
-78.9 percentage of score change
Interval -100.0 to -25.0
-74.4 percentage of score change
Interval -100.0 to 0.0
-60.0 percentage of score change
Interval -100.0 to 33.0
-70.2 percentage of score change
Interval -100.0 to 100.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 52
-61.9 percentage of score change
Interval -100.0 to 200.0
-71.1 percentage of score change
Interval -100.0 to -14.0
-69.3 percentage of score change
Interval -100.0 to 0.0
-73.2 percentage of score change
Interval -100.0 to 17.0
-87.0 percentage of score change
Interval -100.0 to 14.0
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 56
-82.2 percentage of score change
Interval -100.0 to 0.0
-75.9 percentage of score change
Interval -100.0 to 0.0
-71.3 percentage of score change
Interval -100.0 to 0.0
-65.9 percentage of score change
Interval -100.0 to 50.0
-69.7 percentage of score change
Interval -100.0 to 200.0

SECONDARY outcome

Timeframe: 56 Weeks

Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.

DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.

Outcome measures

Outcome measures
Measure
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Baseline
12.0 score on a scale
Interval 1.0 to 27.0
13.8 score on a scale
Interval 1.0 to 27.0
11.9 score on a scale
Interval 2.0 to 30.0
13.4 score on a scale
Interval 2.0 to 30.0
12.6 score on a scale
Interval 1.0 to 29.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 1
11.2 score on a scale
Interval 1.0 to 27.0
12.7 score on a scale
Interval 1.0 to 27.0
12.2 score on a scale
Interval 1.0 to 30.0
14.1 score on a scale
Interval 2.0 to 29.0
12.8 score on a scale
Interval 1.0 to 29.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 2
10.7 score on a scale
Interval 1.0 to 28.0
12.7 score on a scale
Interval 3.0 to 29.0
12.3 score on a scale
Interval 2.0 to 27.0
12.6 score on a scale
Interval 1.0 to 30.0
12.6 score on a scale
Interval 0.0 to 30.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 4
10.2 score on a scale
Interval 1.0 to 28.0
11.2 score on a scale
Interval 1.0 to 28.0
13.3 score on a scale
Interval 1.0 to 30.0
12.5 score on a scale
Interval 0.0 to 29.0
12.7 score on a scale
Interval 0.0 to 29.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 6
7.1 score on a scale
Interval 1.0 to 20.0
9.6 score on a scale
Interval 0.0 to 29.0
10.7 score on a scale
Interval 1.0 to 30.0
11.3 score on a scale
Interval 0.0 to 29.0
10.2 score on a scale
Interval 0.0 to 27.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 8
7.1 score on a scale
Interval 0.0 to 17.0
9.0 score on a scale
Interval 1.0 to 29.0
11.4 score on a scale
Interval 1.0 to 29.0
9.7 score on a scale
Interval 0.0 to 26.0
8.9 score on a scale
Interval 0.0 to 25.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 10
7.1 score on a scale
Interval 1.0 to 21.0
8.3 score on a scale
Interval 1.0 to 28.0
10.6 score on a scale
Interval 1.0 to 26.0
8.0 score on a scale
Interval 0.0 to 27.0
8.0 score on a scale
Interval 1.0 to 22.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 12
5.8 score on a scale
Interval 0.0 to 19.0
7.8 score on a scale
Interval 0.0 to 30.0
9.7 score on a scale
Interval 0.0 to 24.0
7.6 score on a scale
Interval 0.0 to 26.0
7.2 score on a scale
Interval 0.0 to 21.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 14
5.1 score on a scale
Interval 0.0 to 16.0
7.2 score on a scale
Interval 1.0 to 23.0
10.1 score on a scale
Interval 1.0 to 28.0
7.4 score on a scale
Interval 0.0 to 21.0
6.9 score on a scale
Interval 0.0 to 19.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 15
4.4 score on a scale
Interval 0.0 to 16.0
5.9 score on a scale
Interval 0.0 to 18.0
10.3 score on a scale
Interval 0.0 to 28.0
7.5 score on a scale
Interval 1.0 to 25.0
6.2 score on a scale
Interval 0.0 to 17.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 16
4.7 score on a scale
Interval 0.0 to 14.0
6.7 score on a scale
Interval 0.0 to 20.0
9.8 score on a scale
Interval 0.0 to 27.0
7.6 score on a scale
Interval 0.0 to 21.0
6.1 score on a scale
Interval 0.0 to 19.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 18
4.9 score on a scale
Interval 0.0 to 16.0
6.6 score on a scale
Interval 0.0 to 23.0
9.5 score on a scale
Interval 0.0 to 29.0
6.7 score on a scale
Interval 0.0 to 24.0
6.7 score on a scale
Interval 0.0 to 21.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 20
5.0 score on a scale
Interval 0.0 to 17.0
5.6 score on a scale
Interval 0.0 to 20.0
8.8 score on a scale
Interval 0.0 to 23.0
6.7 score on a scale
Interval 0.0 to 27.0
6.2 score on a scale
Interval 0.0 to 23.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 22
4.3 score on a scale
Interval 0.0 to 19.0
5.3 score on a scale
Interval 0.0 to 21.0
8.6 score on a scale
Interval 0.0 to 25.0
6.3 score on a scale
Interval 0.0 to 25.0
5.8 score on a scale
Interval 0.0 to 19.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 24
4.3 score on a scale
Interval 0.0 to 17.0
5.1 score on a scale
Interval 0.0 to 14.0
8.0 score on a scale
Interval 0.0 to 27.0
6.8 score on a scale
Interval 0.0 to 25.0
5.4 score on a scale
Interval 0.0 to 20.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 26
3.7 score on a scale
Interval 0.0 to 14.0
5.2 score on a scale
Interval 0.0 to 16.0
7.5 score on a scale
Interval 0.0 to 27.0
6.7 score on a scale
Interval 0.0 to 28.0
5.2 score on a scale
Interval 0.0 to 17.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 28
3.3 score on a scale
Interval 0.0 to 10.0
4.4 score on a scale
Interval 0.0 to 14.0
6.6 score on a scale
Interval 1.0 to 26.0
6.8 score on a scale
Interval 0.0 to 26.0
5.0 score on a scale
Interval 0.0 to 13.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 30
3.9 score on a scale
Interval 0.0 to 18.0
4.0 score on a scale
Interval 0.0 to 18.0
6.9 score on a scale
Interval 0.0 to 25.0
6.0 score on a scale
Interval 0.0 to 24.0
4.4 score on a scale
Interval 0.0 to 13.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 32
3.6 score on a scale
Interval 0.0 to 16.0
3.5 score on a scale
Interval 0.0 to 11.0
6.1 score on a scale
Interval 0.0 to 26.0
5.8 score on a scale
Interval 0.0 to 30.0
5.3 score on a scale
Interval 0.0 to 16.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 34
2.9 score on a scale
Interval 0.0 to 15.0
3.7 score on a scale
Interval 0.0 to 11.0
4.9 score on a scale
Interval 0.0 to 25.0
5.3 score on a scale
Interval 0.0 to 30.0
5.3 score on a scale
Interval 0.0 to 20.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 36
2.9 score on a scale
Interval 0.0 to 10.0
3.6 score on a scale
Interval 0.0 to 18.0
4.4 score on a scale
Interval 0.0 to 25.0
5.1 score on a scale
Interval 0.0 to 24.0
4.5 score on a scale
Interval 0.0 to 13.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 40
3.3 score on a scale
Interval 0.0 to 11.0
3.7 score on a scale
Interval 0.0 to 10.0
4.1 score on a scale
Interval 0.0 to 24.0
3.7 score on a scale
Interval 0.0 to 20.0
4.8 score on a scale
Interval 0.0 to 20.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 44
3.3 score on a scale
Interval 0.0 to 10.0
3.3 score on a scale
Interval 0.0 to 10.0
1.9 score on a scale
Interval 0.0 to 24.0
3.5 score on a scale
Interval 0.0 to 16.0
3.7 score on a scale
Interval 0.0 to 21.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 48
3.2 score on a scale
Interval 0.0 to 10.0
2.9 score on a scale
Interval 0.0 to 10.0
3.1 score on a scale
Interval 0.0 to 17.0
4.6 score on a scale
Interval 0.0 to 19.0
3.1 score on a scale
Interval 0.0 to 12.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 52
3.7 score on a scale
Interval 0.0 to 23.0
3.8 score on a scale
Interval 0.0 to 16.0
3.3 score on a scale
Interval 0.0 to 19.0
4.1 score on a scale
Interval 0.0 to 27.0
3.1 score on a scale
Interval 0.0 to 12.0
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 56
2.8 score on a scale
Interval 0.0 to 8.0
4.7 score on a scale
Interval 0.0 to 28.0
3.2 score on a scale
Interval 0.0 to 22.0
5.1 score on a scale
Interval 0.0 to 15.0
3.4 score on a scale
Interval 0.0 to 13.0

Adverse Events

KHK4083 150 mg SC Q4W

Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths

KHK4083 600 mg SC Q4W

Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths

KHK4083 300 mg SC Q2W

Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths

KHK4083 600 mg SC Q2W

Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths

Placebo/KHK4083 600 mg

Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
KHK4083 150 mg SC Q4W
n=54 participants at risk
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=53 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 300 mg SC Q2W
n=55 participants at risk
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 participants at risk
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
Eye disorders
Atopic cataract
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Incarcerated umbilical hernia
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Small intestine ulcer
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Pyrexia
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Anal abscess
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Cystitis
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Gastroenteritis rotavirus
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Injury, poisoning and procedural complications
Fall
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Injury, poisoning and procedural complications
Meniscus injury
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Injury, poisoning and procedural complications
Postoperative ileus
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Nervous system disorders
Presyncope
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).

Other adverse events

Other adverse events
Measure
KHK4083 150 mg SC Q4W
n=54 participants at risk
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 600 mg SC Q4W
n=53 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32. To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
KHK4083 300 mg SC Q2W
n=55 participants at risk
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
KHK4083 600 mg SC Q2W
n=54 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
Placebo/KHK4083 600 mg
n=57 participants at risk
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
Ear and labyrinth disorders
Vertigo
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Aphthous ulcer
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
20.8%
11/53 • Number of events 18 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.3%
4/55 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Constipation
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Diarrhoea
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.5%
4/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.6%
2/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Nausea
5.6%
3/54 • Number of events 7 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.6%
2/55 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
14.8%
8/54 • Number of events 8 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.5%
2/57 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Stomatitis
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.4%
4/54 • Number of events 10 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Gastrointestinal disorders
Vomiting
1.9%
1/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Chills
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
12.7%
7/55 • Number of events 10 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
22.2%
12/54 • Number of events 14 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Fatigue
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.5%
2/57 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Injection site pain
3.7%
2/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 13 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Injection site swelling
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.5%
3/55 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Malaise
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
General disorders
Pyrexia
13.0%
7/54 • Number of events 7 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
17.0%
9/53 • Number of events 9 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
18.2%
10/55 • Number of events 11 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
20.4%
11/54 • Number of events 11 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.3%
3/57 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Influenza
9.3%
5/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Kaposi's varicelliform eruption
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Nasopharyngitis
24.1%
13/54 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
20.8%
11/53 • Number of events 16 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
21.8%
12/55 • Number of events 16 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
35.2%
19/54 • Number of events 25 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
22.8%
13/57 • Number of events 18 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Oral herpes
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.3%
4/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.4%
4/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Pharyngitis
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Tinea pedis
3.7%
2/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Infections and infestations
Upper respiratory tract infection
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.5%
4/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.3%
4/55 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Musculoskeletal and connective tissue disorders
Arthralgia
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.8%
2/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
9.3%
5/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Musculoskeletal and connective tissue disorders
Back pain
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Nervous system disorders
Headache
7.4%
4/54 • Number of events 12 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
11.3%
6/53 • Number of events 9 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
10.9%
6/55 • Number of events 20 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
9.3%
5/54 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
8.8%
5/57 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Renal and urinary disorders
Nephrolithiasis
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Respiratory, thoracic and mediastinal disorders
Cough
7.4%
4/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
7.3%
4/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Skin and subcutaneous tissue disorders
Acne
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
9.4%
5/53 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
12.7%
7/55 • Number of events 8 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.3%
3/57 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Skin and subcutaneous tissue disorders
Dermatitis atopic
35.2%
19/54 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
22.6%
12/53 • Number of events 12 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
32.7%
18/55 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
37.0%
20/54 • Number of events 22 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
42.1%
24/57 • Number of events 28 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
Skin and subcutaneous tissue disorders
Miliaria
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).

Additional Information

Research & Development Planning Department, Research & Development Division

Kyowa Kirin Co., Ltd.

Phone: +81-3-5205-7200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60