Trial Outcomes & Findings for Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (NCT NCT03363854)
NCT ID: NCT03363854
Last Updated: 2025-03-11
Results Overview
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
Week 16
Results posted on
2025-03-11
Participant Flow
After the participant gave informed consent, they went through a 2- to 6-week screening period for washout of previous atopic dermatitis medication and disallowed medication. The participant was assigned treatment at Week 0.
Participant milestones
| Measure |
Tralokinumab Q2W+TCS
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
Safety Follow-up
Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
|
|---|---|---|---|---|---|---|---|---|
|
Initial Treatment Period
STARTED
|
253
|
127
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
COMPLETED
|
235
|
120
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
NOT COMPLETED
|
18
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Continuation Treatment Period
STARTED
|
0
|
0
|
69
|
69
|
95
|
79
|
41
|
0
|
|
Continuation Treatment Period
COMPLETED
|
0
|
0
|
68
|
65
|
87
|
72
|
38
|
0
|
|
Continuation Treatment Period
NOT COMPLETED
|
0
|
0
|
1
|
4
|
8
|
7
|
3
|
0
|
|
Safety Follow-up Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
278
|
|
Safety Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
62
|
|
Safety Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
216
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of participants analysed is different from the number of participants randomised due to missing data.
Baseline characteristics by cohort
| Measure |
Tralokinumab Q2W+TCS
n=253 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=127 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
237 Participants
n=253 Participants
|
119 Participants
n=127 Participants
|
356 Participants
n=380 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=253 Participants
|
8 Participants
n=127 Participants
|
24 Participants
n=380 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 15.3 • n=253 Participants
|
37.7 years
STANDARD_DEVIATION 14.8 • n=127 Participants
|
39.1 years
STANDARD_DEVIATION 15.2 • n=380 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=253 Participants
|
43 Participants
n=127 Participants
|
171 Participants
n=380 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=253 Participants
|
84 Participants
n=127 Participants
|
209 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
203 Participants
n=253 Participants
|
85 Participants
n=127 Participants
|
288 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
23 Participants
n=253 Participants
|
12 Participants
n=127 Participants
|
35 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
17 Participants
n=253 Participants
|
24 Participants
n=127 Participants
|
41 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=253 Participants
|
1 Participants
n=127 Participants
|
2 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=253 Participants
|
5 Participants
n=127 Participants
|
14 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Race · Not Hispanic or Latino
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black or African American
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
25 Participants
n=253 Participants
|
9 Participants
n=127 Participants
|
34 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
228 Participants
n=253 Participants
|
118 Participants
n=127 Participants
|
346 Participants
n=380 Participants
|
|
Region of Enrollment
Belgium
|
15 Participants
n=253 Participants
|
4 Participants
n=127 Participants
|
19 Participants
n=380 Participants
|
|
Region of Enrollment
Canada
|
34 Participants
n=253 Participants
|
26 Participants
n=127 Participants
|
60 Participants
n=380 Participants
|
|
Region of Enrollment
Germany
|
42 Participants
n=253 Participants
|
15 Participants
n=127 Participants
|
57 Participants
n=380 Participants
|
|
Region of Enrollment
Netherlands
|
9 Participants
n=253 Participants
|
7 Participants
n=127 Participants
|
16 Participants
n=380 Participants
|
|
Region of Enrollment
Poland
|
48 Participants
n=253 Participants
|
19 Participants
n=127 Participants
|
67 Participants
n=380 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=253 Participants
|
15 Participants
n=127 Participants
|
27 Participants
n=380 Participants
|
|
Region of Enrollment
United Kingdom
|
21 Participants
n=253 Participants
|
13 Participants
n=127 Participants
|
34 Participants
n=380 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=253 Participants
|
28 Participants
n=127 Participants
|
100 Participants
n=380 Participants
|
|
Age at onset of atopic dermatitis
|
4.0 years
n=253 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
2.0 years
n=126 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
4.0 years
n=379 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
|
Duration of atopic dermatitis
|
28.0 years
STANDARD_DEVIATION 16.5 • n=253 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
28.7 years
STANDARD_DEVIATION 15.0 • n=126 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
28.2 years
STANDARD_DEVIATION 16.0 • n=379 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
|
Body surface area with atopic dermatitis
|
47.6 percentage affected
STANDARD_DEVIATION 23.3 • n=253 Participants
|
49.0 percentage affected
STANDARD_DEVIATION 25.9 • n=127 Participants
|
48.1 percentage affected
STANDARD_DEVIATION 24.2 • n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Clear
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Almost clear
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Mild
|
0 Participants
n=253 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Moderate
|
136 Participants
n=253 Participants
|
66 Participants
n=127 Participants
|
202 Participants
n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Severe
|
116 Participants
n=253 Participants
|
60 Participants
n=127 Participants
|
176 Participants
n=380 Participants
|
|
Investigator's Global Assessment (IGA)
Missing
|
1 Participants
n=253 Participants
|
1 Participants
n=127 Participants
|
2 Participants
n=380 Participants
|
|
Eczema Area and Severity Index (EASI)
|
28.81 units on a scale
STANDARD_DEVIATION 11.97 • n=252 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
30.42 units on a scale
STANDARD_DEVIATION 12.78 • n=126 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
29.35 units on a scale
STANDARD_DEVIATION 12.25 • n=378 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
|
Worst Daily Pruritus numeric rating scale (NRS) (weekly average)
|
7.67 units on a scale
STANDARD_DEVIATION 1.51 • n=251 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
7.86 units on a scale
STANDARD_DEVIATION 1.49 • n=126 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
7.74 units on a scale
STANDARD_DEVIATION 1.51 • n=377 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
|
Scoring Atopic Dermatitis (SCORAD)
|
66.95 units on a scale
STANDARD_DEVIATION 13.26 • n=252 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
68.86 units on a scale
STANDARD_DEVIATION 13.19 • n=126 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
67.59 units on a scale
STANDARD_DEVIATION 13.25 • n=378 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
|
Dermatology Life Quality Index (DLQI)
|
17.58 units on a scale
STANDARD_DEVIATION 7.07 • n=250 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
17.19 units on a scale
STANDARD_DEVIATION 7.15 • n=125 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
17.45 units on a scale
STANDARD_DEVIATION 7.09 • n=375 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
|
PRIMARY outcome
Timeframe: Week 16Population: Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
|
98 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16
|
141 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).
Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=249 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16
|
113 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
|
-37.7 units on a scale
Standard Error 1.25
|
-26.8 units on a scale
Standard Error 1.80
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
|
-11.7 units on a scale
Standard Error 0.39
|
-8.8 units on a scale
Standard Error 0.56
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16, Week 16 to Week 32Population: Safety analysis set (378 participants). Data was collected for the treatment groups applicable in each treatment period, i.e. tralokinumab Q2W+TCS and placebo+TCS treatment groups in the initial treatment period and the 5 continuation treatment groups (see table below) in the continuation treatment period.
Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
n=69 Participants
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
n=69 Participants
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
n=95 Participants
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
n=79 Participants
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
n=41 Participants
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Frequency of Anti-drug Antibodies (ADA)
Continuation treatment period (Week 16 to Week 32) · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Continuation treatment period (Week 16 to Week 32) · Perishing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Continuation treatment period (Week 16 to Week 32) · Negative
|
0 Participants
|
0 Participants
|
66 Participants
|
63 Participants
|
92 Participants
|
74 Participants
|
37 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Initial treatment period (Week 0 to Week 16) · Positive
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Initial treatment period (Week 0 to Week 16) · Perishing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Initial treatment period (Week 0 to Week 16) · Negative
|
246 Participants
|
123 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Initial treatment period (Week 0 to Week 16) · No post-baseline ADA assessment
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Anti-drug Antibodies (ADA)
Continuation treatment period (Week 16 to Week 32) · No post-baseline ADA assessment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1-2 to Week 15-16Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 11-12
|
11.6 g
Standard Error 1.38
|
19.6 g
Standard Error 2.00
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 15-16
|
11.6 g
Standard Error 1.57
|
20.2 g
Standard Error 2.27
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 1-2
|
29.3 g
Standard Error 2.45
|
32.8 g
Standard Error 3.47
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 3-4
|
19.7 g
Standard Error 1.86
|
26.6 g
Standard Error 2.66
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 5-6
|
18.5 g
Standard Error 1.72
|
23.2 g
Standard Error 2.46
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 7-8
|
17.0 g
Standard Error 2.04
|
24.3 g
Standard Error 2.93
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 9-10
|
14.8 g
Standard Error 1.66
|
23.9 g
Standard Error 2.38
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes
Week 13-14
|
12.7 g
Standard Error 1.61
|
23.0 g
Standard Error 2.33
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1-2 to Week 15-16Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 1-2
|
40.1 g
Standard Error 3.22
|
40.1 g
Standard Error 4.57
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 3-4
|
32.4 g
Standard Error 3.00
|
31.3 g
Standard Error 4.27
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 5-6
|
29.2 g
Standard Error 2.89
|
30.6 g
Standard Error 4.13
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 7-8
|
25.2 g
Standard Error 2.89
|
30.0 g
Standard Error 4.15
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 9-10
|
22.5 g
Standard Error 2.61
|
26.9 g
Standard Error 3.76
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 11-12
|
16.9 g
Standard Error 2.23
|
23.1 g
Standard Error 3.22
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 13-14
|
16.6 g
Standard Error 2.22
|
25.5 g
Standard Error 3.23
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes
Week 15-16
|
15.3 g
Standard Error 2.26
|
24.8 g
Standard Error 3.27
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set. All observed data
Assessed as appearance of new flares since previous visit.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Number of Atopic Dermatitis Flares Through Week 16
|
119 number of flares
|
75 number of flares
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 to Week 16Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 5
|
3.2 days
Standard Error 0.17
|
2.7 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 6
|
3.1 days
Standard Error 0.18
|
2.8 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 1
|
2.6 days
Standard Error 0.17
|
2.5 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 2
|
3.0 days
Standard Error 0.18
|
2.6 days
Standard Error 0.27
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 3
|
2.9 days
Standard Error 0.17
|
2.7 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 4
|
3.1 days
Standard Error 0.17
|
2.7 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 7
|
3.3 days
Standard Error 0.17
|
2.7 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 8
|
3.3 days
Standard Error 0.18
|
3.0 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 9
|
3.6 days
Standard Error 0.17
|
2.6 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 10
|
3.4 days
Standard Error 0.17
|
2.7 days
Standard Error 0.25
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 11
|
3.6 days
Standard Error 0.18
|
2.7 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 12
|
3.4 days
Standard Error 0.18
|
2.7 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 13
|
3.5 days
Standard Error 0.18
|
2.7 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 14
|
3.3 days
Standard Error 0.18
|
2.6 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 15
|
3.5 days
Standard Error 0.18
|
2.8 days
Standard Error 0.26
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Without Topical Treatment Use From Baseline to Week 16
Week 16
|
3.4 days
Standard Error 0.19
|
3.0 days
Standard Error 0.27
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16
|
200 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16
|
83 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=229 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=108 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
|
-21.0 units on a scale
Standard Error 0.67
|
-15.6 units on a scale
Standard Error 0.96
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set
SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
|
154 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis set
SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=252 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=126 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
|
60 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.
Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=221 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=100 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average)
|
-4.1 units on a scale
Standard Error 0.15
|
-2.9 units on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Participants in the full analysis set with DLQI of at least 4 at baseline (Week 0).
DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=248 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=123 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4
|
207 Participants
|
81 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved IGA score of 0 or 1 at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=48 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=49 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab
|
43 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved at least 75% reduction in EASI at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab Q2W+TCS
n=67 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Placebo+TCS
n=65 Participants
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period - Tralokinumab R/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab R/Q4W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Tralokinumab NR/Q2W+TCS
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo NR/Tralokinumab Q2W+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period - Placebo R/Placebo+TCS
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
|---|---|---|---|---|---|---|---|
|
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab
|
62 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Initial Treatment Period: Tralokinumab Q2W+TCS
Serious events: 2 serious events
Other events: 118 other events
Deaths: 0 deaths
Initial Treatment Period: Placebo+TCS
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Continuation Treatment Period: Tralokinumab R/Q2W+TCS
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Continuation Treatment Period: Tralokinumab R/Q4W+TCS
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Continuation Treatment Period: Tralokinumab NR/Q2W+TCS
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Continuation Treatment Period: Placebo NR/Tralokinumab Q2W+TCS
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Continuation Treatment Period: Placebo R/Placebo+TCS
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Safety Follow-up
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Treatment Period: Tralokinumab Q2W+TCS
n=252 participants at risk
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Initial Treatment Period: Placebo+TCS
n=126 participants at risk
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period: Tralokinumab R/Q2W+TCS
n=69 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Tralokinumab R/Q4W+TCS
n=69 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Tralokinumab NR/Q2W+TCS
n=95 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Placebo NR/Tralokinumab Q2W+TCS
n=79 participants at risk
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Placebo R/Placebo+TCS
n=41 participants at risk
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
Safety Follow-up
n=278 participants at risk
Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.40%
1/252 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Immune system disorders
Anaphylactic reaction
|
0.40%
1/252 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.1%
1/95 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.4%
1/41 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.36%
1/278 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.36%
1/278 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Psychiatric disorders
Depression
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.1%
1/95 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/95 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/79 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.36%
1/278 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
Other adverse events
| Measure |
Initial Treatment Period: Tralokinumab Q2W+TCS
n=252 participants at risk
Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed.
Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
|
Initial Treatment Period: Placebo+TCS
n=126 participants at risk
Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed.
Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
|
Continuation Treatment Period: Tralokinumab R/Q2W+TCS
n=69 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Tralokinumab R/Q4W+TCS
n=69 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Tralokinumab NR/Q2W+TCS
n=95 participants at risk
Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Placebo NR/Tralokinumab Q2W+TCS
n=79 participants at risk
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
|
Continuation Treatment Period: Placebo R/Placebo+TCS
n=41 participants at risk
Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32).
Participants were administered placebo Q2W from Week 16 to Week 30.
|
Safety Follow-up
n=278 participants at risk
Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
8/252 • Number of events 8 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.6%
2/126 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.8%
4/69 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.1%
1/95 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.5%
2/79 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.9%
2/41 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.36%
1/278 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/252 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.3%
3/69 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.8%
4/69 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
3.2%
3/95 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.3%
1/79 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.72%
2/278 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
General disorders
Injection site reaction
|
6.7%
17/252 • Number of events 30 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/126 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
7.2%
5/69 • Number of events 14 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.8%
4/69 • Number of events 9 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.3%
5/95 • Number of events 5 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.5%
2/79 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/41 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
28/252 • Number of events 32 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
3.2%
4/126 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.8%
4/69 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/69 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
3.2%
3/95 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
3.8%
3/79 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.4%
1/41 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Oral herpes
|
1.6%
4/252 • Number of events 6 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.79%
1/126 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.3%
3/69 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
5.8%
4/69 • Number of events 4 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.2%
4/95 • Number of events 5 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.5%
2/79 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.4%
1/41 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
19/252 • Number of events 21 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.8%
6/126 • Number of events 7 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
10.1%
7/69 • Number of events 8 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.3%
3/69 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
6.3%
6/95 • Number of events 7 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
3.8%
3/79 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.9%
2/41 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.72%
2/278 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
19.4%
49/252 • Number of events 64 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
11.1%
14/126 • Number of events 18 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
17.4%
12/69 • Number of events 13 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
13.0%
9/69 • Number of events 10 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
21.1%
20/95 • Number of events 28 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
19.0%
15/79 • Number of events 15 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
17.1%
7/41 • Number of events 8 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.00%
0/278 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Nervous system disorders
Headache
|
8.7%
22/252 • Number of events 26 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.8%
6/126 • Number of events 9 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.9%
2/69 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
7.2%
5/69 • Number of events 5 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
7.4%
7/95 • Number of events 7 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.5%
2/79 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
2.4%
1/41 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.1%
3/278 • Number of events 3 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.4%
6/252 • Number of events 8 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
7.9%
10/126 • Number of events 12 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
1.4%
1/69 • Number of events 1 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
8.4%
8/95 • Number of events 8 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
7.6%
6/79 • Number of events 7 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
4.9%
2/41 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
0.72%
2/278 • Number of events 2 • Initial treatment period (Week 0 to Week 16), continuation treatment period (Week 16 to Week 32), safety follow-up (Week 32 to Week 46).
The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all phase 3 clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER