Trial Outcomes & Findings for A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (NCT NCT05923099)
NCT ID: NCT05923099
Last Updated: 2026-02-12
Results Overview
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
262 participants
Primary outcome timeframe
From baseline to Week 16
Results posted on
2026-02-12
Participant Flow
This trial was conducted at sites in 11 countries (Canada, Czech Republic, France, Germany, Hungary, Japan, Poland, Romania, Spain, United Kingdom, and United States).
Participants were randomized 1:1:1:1:1 to 5 different treatment groups (4 different dose regimens of LEO 138559 and placebo).
Participant milestones
| Measure |
Dose Regimen 1
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16
Placebo: Placebo given by injection just under the skin. Placebo contains no active ingredients.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
52
|
53
|
52
|
|
Overall Study
COMPLETED
|
40
|
45
|
40
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
12
|
15
|
17
|
Reasons for withdrawal
| Measure |
Dose Regimen 1
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16
Placebo: Placebo given by injection just under the skin. Placebo contains no active ingredients.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
1
|
1
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
8
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Protocol-specified withdrawal criteria, withdrawal by investigator, prohibited medication used
|
1
|
1
|
1
|
1
|
1
|
Baseline Characteristics
A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Total
n=262 Participants
Total of all reporting groups
|
Dose Regimen 1
n=52 Participants
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
n=53 Participants
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
n=52 Participants
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
n=53 Participants
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
n=52 Participants
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
Placebo: Placebo given by injection just under the skin. Placebo contains no active ingredients.
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 14.0 • n=140 Participants
|
34.9 years
STANDARD_DEVIATION 13.8 • n=41 Participants
|
35.7 years
STANDARD_DEVIATION 14.3 • n=1581 Participants
|
39.0 years
STANDARD_DEVIATION 15.7 • n=4626 Participants
|
35.9 years
STANDARD_DEVIATION 14.4 • n=72 Participants
|
32.1 years
STANDARD_DEVIATION 11.1
|
|
Age, Customized
18 to <65 years
|
253 Participants
n=140 Participants
|
50 Participants
n=41 Participants
|
51 Participants
n=1581 Participants
|
50 Participants
n=4626 Participants
|
50 Participants
n=72 Participants
|
52 Participants
|
|
Age, Customized
65 to <85 years
|
9 Participants
n=140 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=140 Participants
|
26 Participants
n=41 Participants
|
24 Participants
n=1581 Participants
|
26 Participants
n=4626 Participants
|
28 Participants
n=72 Participants
|
26 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=140 Participants
|
26 Participants
n=41 Participants
|
29 Participants
n=1581 Participants
|
26 Participants
n=4626 Participants
|
25 Participants
n=72 Participants
|
26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=140 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
216 Participants
n=140 Participants
|
42 Participants
n=41 Participants
|
42 Participants
n=1581 Participants
|
41 Participants
n=4626 Participants
|
47 Participants
n=72 Participants
|
44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=140 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=140 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=140 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
13 Participants
n=72 Participants
|
11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=140 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=140 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
0 Participants
|
|
Race (NIH/OMB)
White
|
172 Participants
n=140 Participants
|
33 Participants
n=41 Participants
|
34 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
35 Participants
n=72 Participants
|
34 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=140 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=140 Participants
|
7 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
6 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=140 Participants
|
2 participants
n=41 Participants
|
4 participants
n=1581 Participants
|
7 participants
n=4626 Participants
|
4 participants
n=72 Participants
|
3 participants
|
|
Region of Enrollment
Romania
|
2 participants
n=140 Participants
|
1 participants
n=41 Participants
|
1 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=72 Participants
|
0 participants
|
|
Region of Enrollment
Hungary
|
8 participants
n=140 Participants
|
1 participants
n=41 Participants
|
0 participants
n=1581 Participants
|
2 participants
n=4626 Participants
|
3 participants
n=72 Participants
|
2 participants
|
|
Region of Enrollment
United States
|
26 participants
n=140 Participants
|
6 participants
n=41 Participants
|
3 participants
n=1581 Participants
|
5 participants
n=4626 Participants
|
8 participants
n=72 Participants
|
4 participants
|
|
Region of Enrollment
Czechia
|
25 participants
n=140 Participants
|
5 participants
n=41 Participants
|
5 participants
n=1581 Participants
|
4 participants
n=4626 Participants
|
5 participants
n=72 Participants
|
6 participants
|
|
Region of Enrollment
Japan
|
34 participants
n=140 Participants
|
6 participants
n=41 Participants
|
7 participants
n=1581 Participants
|
7 participants
n=4626 Participants
|
7 participants
n=72 Participants
|
7 participants
|
|
Region of Enrollment
Poland
|
54 participants
n=140 Participants
|
12 participants
n=41 Participants
|
9 participants
n=1581 Participants
|
9 participants
n=4626 Participants
|
11 participants
n=72 Participants
|
13 participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=140 Participants
|
2 participants
n=41 Participants
|
2 participants
n=1581 Participants
|
3 participants
n=4626 Participants
|
2 participants
n=72 Participants
|
5 participants
|
|
Region of Enrollment
France
|
23 participants
n=140 Participants
|
7 participants
n=41 Participants
|
5 participants
n=1581 Participants
|
4 participants
n=4626 Participants
|
1 participants
n=72 Participants
|
6 participants
|
|
Region of Enrollment
Germany
|
38 participants
n=140 Participants
|
7 participants
n=41 Participants
|
13 participants
n=1581 Participants
|
7 participants
n=4626 Participants
|
7 participants
n=72 Participants
|
4 participants
|
|
Region of Enrollment
Spain
|
18 participants
n=140 Participants
|
3 participants
n=41 Participants
|
4 participants
n=1581 Participants
|
4 participants
n=4626 Participants
|
5 participants
n=72 Participants
|
2 participants
|
|
EASI score
|
26.15 scores on a scale
STANDARD_DEVIATION 10.19 • n=140 Participants
|
25.74 scores on a scale
STANDARD_DEVIATION 9.51 • n=41 Participants
|
25.61 scores on a scale
STANDARD_DEVIATION 8.95 • n=1581 Participants
|
26.73 scores on a scale
STANDARD_DEVIATION 11.28 • n=4626 Participants
|
26.53 scores on a scale
STANDARD_DEVIATION 10.41 • n=72 Participants
|
26.13 scores on a scale
STANDARD_DEVIATION 10.97
|
PRIMARY outcome
Timeframe: From baseline to Week 16Population: For the primary efficacy endpoint, analyzed population was Full Analysis Set (FAS).
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
Outcome measures
| Measure |
Dose Regimen 1
n=52 Participants
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
n=53 Participants
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
n=52 Participants
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
n=53 Participants
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
n=52 Participants
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16
Placebo: Placebo given by injection just under the skin. Placebo contains no active ingredients.
|
|---|---|---|---|---|---|
|
Percent Change in Eczema Area and Severity Index (EASI) Score
|
-61.15 percent of change
Interval -71.38 to -50.91
|
-57.05 percent of change
Interval -67.13 to -46.96
|
-64.27 percent of change
Interval -74.55 to -53.99
|
-51.42 percent of change
Interval -61.91 to -40.92
|
-41.74 percent of change
Interval -52.18 to -31.31
|
SECONDARY outcome
Timeframe: From baseline (Week 0) to Week 16Population: For the safety analysis, analyzed population was Safety Analysis Set (SAF).
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP.
Outcome measures
| Measure |
Dose Regimen 1
n=52 Participants
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
n=53 Participants
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
n=52 Participants
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
n=53 Participants
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
n=52 Participants
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16
Placebo: Placebo given by injection just under the skin. Placebo contains no active ingredients.
|
|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
98 adverse events
|
124 adverse events
|
83 adverse events
|
118 adverse events
|
78 adverse events
|
Adverse Events
Dose Regimen 1
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose Regimen 2
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Dose Regimen 3
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Dose Regimen 4
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo Regimen
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Regimen 1
n=52 participants at risk
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
n=53 participants at risk
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
n=52 participants at risk
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
n=53 participants at risk
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
n=52 participants at risk
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16 Placebo: Placebo given by injection just under the skin
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Psychiatric disorders
Mania
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
Other adverse events
| Measure |
Dose Regimen 1
n=52 participants at risk
Dose A, the highest dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 2
n=53 participants at risk
Dose B, medium-high dose of LEO 138559 \[Temtokibart\], given every week from Week 0 to Week 2, then every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 3
n=52 participants at risk
Dose A, highest dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose C (medium-low dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16.
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Dose Regimen 4
n=53 participants at risk
Dose C, medium-low dose of LEO 138559 \[Temtokibart\], given at Week 0 and Week 2, then dose D (lowest dose of LEO 138559 \[Temtokibart\]) every 2 weeks from Week 4 to Week 16
LEO 138559: LEO 138559 \[Temtokibart\] given by injection just under the skin
|
Placebo Regimen
n=52 participants at risk
Placebo every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16 Placebo: Placebo given by injection just under the skin
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
11.3%
6/53 • Number of events 6 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
General disorders
Fatigue
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
General disorders
Pyrexia
|
5.8%
3/52 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 4 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
3.8%
2/52 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
9.4%
5/53 • Number of events 5 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Infections and infestations
Conjunctivitis
|
3.8%
2/52 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
3.8%
2/52 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Infections and infestations
Nasopharyngitis
|
28.8%
15/52 • Number of events 18 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
20.8%
11/53 • Number of events 15 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
17.3%
9/52 • Number of events 13 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
24.5%
13/53 • Number of events 15 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
21.2%
11/52 • Number of events 13 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.8%
3/52 • Number of events 4 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
7.5%
4/53 • Number of events 5 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/53 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Nervous system disorders
Headache
|
7.7%
4/52 • Number of events 6 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 5 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
3.8%
2/52 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
3.8%
2/52 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/52 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
1.9%
1/53 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
5.7%
3/53 • Number of events 6 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
0.00%
0/52 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.7%
4/52 • Number of events 4 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
18.9%
10/53 • Number of events 12 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
23.1%
12/52 • Number of events 17 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
28.3%
15/53 • Number of events 24 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
23.1%
12/52 • Number of events 18 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
An event will be considered treatment emergent if started after the first dose of IMP or if started before the first dose of IMP and worsened in severity after first dose of IMP. An event will not be considered treatment-emergent if starting 18 weeks after the last dose of IMP. Any event that occurred prior to IMP administration was not considered treatment-emergent, as it was not triggered by the intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 12 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 12 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
- Publication restrictions are in place
Restriction type: OTHER