Trial Outcomes & Findings for A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy (NCT NCT05958407)
NCT ID: NCT05958407
Last Updated: 2026-08-05
Results Overview
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
COMPLETED
PHASE3
235 participants
At Week 16
2026-08-05
Participant Flow
This trial was conducted at sites in Asia, Europe, and North America.
Participants were randomized 2:1 to treatment with tralokinumab or placebo.
Participant milestones
| Measure |
Tralokinumab
Tralokinumab was administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 32 weeks.
|
Placebo + Tralokinumab
Placebo was administered for 16 weeks (double-blinded period) prior to roll-over to a 16 week open-label period where tralokinumab was administered. After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks followed by administration of a tralokinumab dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Double-blinded Period
STARTED
|
156
|
79
|
|
Double-blinded Period
COMPLETED
|
149
|
71
|
|
Double-blinded Period
NOT COMPLETED
|
7
|
8
|
|
Transfer to Open-label Treatment
STARTED
|
149
|
71
|
|
Transfer to Open-label Treatment
COMPLETED
|
144
|
70
|
|
Transfer to Open-label Treatment
NOT COMPLETED
|
5
|
1
|
|
Open-label Period
STARTED
|
144
|
70
|
|
Open-label Period
COMPLETED
|
133
|
67
|
|
Open-label Period
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Tralokinumab
Tralokinumab was administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 32 weeks.
|
Placebo + Tralokinumab
Placebo was administered for 16 weeks (double-blinded period) prior to roll-over to a 16 week open-label period where tralokinumab was administered. After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks followed by administration of a tralokinumab dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Double-blinded Period
Pregnancy
|
0
|
1
|
|
Double-blinded Period
Adverse Event
|
1
|
2
|
|
Double-blinded Period
Lost to Follow-up
|
0
|
1
|
|
Double-blinded Period
Lack of Efficacy
|
0
|
1
|
|
Double-blinded Period
Withdrawal by Subject
|
6
|
3
|
|
Transfer to Open-label Treatment
Adverse Event
|
2
|
0
|
|
Transfer to Open-label Treatment
Withdrawal by Subject
|
2
|
1
|
|
Transfer to Open-label Treatment
Personal reasons
|
1
|
0
|
|
Open-label Period
Adverse Event
|
1
|
1
|
|
Open-label Period
Lost to Follow-up
|
1
|
1
|
|
Open-label Period
Lack of Efficacy
|
1
|
0
|
|
Open-label Period
Withdrawal by Subject
|
6
|
1
|
|
Open-label Period
Personal reasons
|
2
|
0
|
Baseline Characteristics
Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
Baseline characteristics by cohort
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 32 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period) prior to roll-over to a 16 week open-label period where tralokinumab was administered. After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks followed by administration of a tralokinumab dose (s.c.) every two weeks for 16 weeks.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 14.9 • n=156 Participants
|
41.5 years
STANDARD_DEVIATION 13.7 • n=79 Participants
|
39.9 years
STANDARD_DEVIATION 14.5 • n=235 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=156 Participants
|
55 Participants
n=79 Participants
|
149 Participants
n=235 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=156 Participants
|
24 Participants
n=79 Participants
|
86 Participants
n=235 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=156 Participants
|
8 Participants
n=79 Participants
|
21 Participants
n=235 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=156 Participants
|
71 Participants
n=79 Participants
|
214 Participants
n=235 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=156 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=235 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=156 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=235 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=156 Participants
|
17 Participants
n=79 Participants
|
57 Participants
n=235 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=156 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=235 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=156 Participants
|
6 Participants
n=79 Participants
|
15 Participants
n=235 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=156 Participants
|
54 Participants
n=79 Participants
|
158 Participants
n=235 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=156 Participants
|
1 Participants
n=79 Participants
|
2 Participants
n=235 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=156 Participants
|
1 Participants
n=79 Participants
|
1 Participants
n=235 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=156 Participants
|
1 Participants
n=79 Participants
|
8 Participants
n=235 Participants
|
|
Region of Enrollment
Canada
|
38 Participants
n=156 Participants
|
18 Participants
n=79 Participants
|
56 Participants
n=235 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=156 Participants
|
4 Participants
n=79 Participants
|
5 Participants
n=235 Participants
|
|
Region of Enrollment
Germany
|
15 Participants
n=156 Participants
|
6 Participants
n=79 Participants
|
21 Participants
n=235 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=156 Participants
|
3 Participants
n=79 Participants
|
5 Participants
n=235 Participants
|
|
Region of Enrollment
Poland
|
15 Participants
n=156 Participants
|
7 Participants
n=79 Participants
|
22 Participants
n=235 Participants
|
|
Region of Enrollment
South Korea
|
21 Participants
n=156 Participants
|
11 Participants
n=79 Participants
|
32 Participants
n=235 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=156 Participants
|
2 Participants
n=79 Participants
|
9 Participants
n=235 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=156 Participants
|
2 Participants
n=79 Participants
|
5 Participants
n=235 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=156 Participants
|
25 Participants
n=79 Participants
|
72 Participants
n=235 Participants
|
|
Investigator's Global Assessment - AHE
Moderate disease
|
114 Participants
n=156 Participants
|
56 Participants
n=79 Participants
|
170 Participants
n=235 Participants
|
|
Investigator's Global Assessment - AHE
Severe disease
|
42 Participants
n=156 Participants
|
23 Participants
n=79 Participants
|
65 Participants
n=235 Participants
|
|
HECSI Score
|
83.9 units on a scale
STANDARD_DEVIATION 51.8 • n=156 Participants
|
77.7 units on a scale
STANDARD_DEVIATION 41.4 • n=79 Participants
|
81.8 units on a scale
STANDARD_DEVIATION 48.5 • n=235 Participants
|
|
HESD Itch Score (Weekly Average)
|
7.28 units on a scale
STANDARD_DEVIATION 1.60 • n=155 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
7.52 units on a scale
STANDARD_DEVIATION 1.66 • n=78 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
7.36 units on a scale
STANDARD_DEVIATION 1.62 • n=233 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
|
HESD Pain Score (Weekly Average)
|
6.51 units on a scale
STANDARD_DEVIATION 2.23 • n=155 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
7.07 units on a scale
STANDARD_DEVIATION 2.15 • n=78 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
6.70 units on a scale
STANDARD_DEVIATION 2.21 • n=233 Participants • Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
|
|
HEIS Score
|
2.54 units on a scale
STANDARD_DEVIATION 0.86 • n=154 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
2.69 units on a scale
STANDARD_DEVIATION 0.85 • n=77 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
2.59 units on a scale
STANDARD_DEVIATION 0.86 • n=231 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
|
DLQI Score
|
14.2 units on a scale
STANDARD_DEVIATION 7.0 • n=154 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
14.8 units on a scale
STANDARD_DEVIATION 7.1 • n=77 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
14.4 units on a scale
STANDARD_DEVIATION 7.1 • n=231 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
|
WPAI:AHE Presenteeism Score
|
49.63 units on a scale
STANDARD_DEVIATION 28.74 • n=109 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
47.04 units on a scale
STANDARD_DEVIATION 31.84 • n=54 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
48.77 units on a scale
STANDARD_DEVIATION 29.73 • n=163 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
|
WPAI:AHE Absenteeism Score
|
8.13 units on a scale
STANDARD_DEVIATION 18.03 • n=109 Participants • Data is not available for 47 participants in the tralokinumab group and for 23 participants in the placebo group.
|
8.72 units on a scale
STANDARD_DEVIATION 22.02 • n=56 Participants • Data is not available for 47 participants in the tralokinumab group and for 23 participants in the placebo group.
|
8.33 units on a scale
STANDARD_DEVIATION 19.41 • n=165 Participants • Data is not available for 47 participants in the tralokinumab group and for 23 participants in the placebo group.
|
|
WPAI:AHE Work Productivity
|
51.91 units on a scale
STANDARD_DEVIATION 29.59 • n=109 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
48.32 units on a scale
STANDARD_DEVIATION 32.13 • n=54 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
50.72 units on a scale
STANDARD_DEVIATION 30.40 • n=163 Participants • Data is not available for 47 participants in the tralokinumab group and for 25 participants in the placebo group.
|
|
WPAI+CIQ:AHE Activity Impairment Score
|
57.08 units on a scale
STANDARD_DEVIATION 26.91 • n=154 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
61.30 units on a scale
STANDARD_DEVIATION 27.02 • n=77 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
58.48 units on a scale
STANDARD_DEVIATION 26.96 • n=231 Participants • Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
|
PRIMARY outcome
Timeframe: At Week 16Population: Analyzed population: Full Analysis Set (FAS) - all randomized participants who were exposed to at least dose of investigational medicinal product (IMP).
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
|
40.0 percentage of responders
Interval 31.3 to 49.4
|
10.6 percentage of responders
Interval 5.0 to 20.9
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Having a ≥2-point Reduction in IGA-AHE Score
|
40.1 percentage of responders
Interval 31.4 to 49.3
|
10.6 percentage of responders
Interval 5.4 to 19.8
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Week 16Population: Analyzed population: FAS
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
|
64.1 percentage of responders
Interval 55.3 to 72.0
|
33.8 percentage of responders
Interval 23.4 to 46.0
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-50 is defined as at least 50% improvement in HECSI score from baseline.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Having a Decrease in HECSI of at Least 50% (HECSI-50)
|
79.7 percentage of responders
Interval 71.9 to 85.8
|
50.7 percentage of responders
Interval 38.7 to 62.7
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Having a Decrease in HECSI of at Least 90% (HECSI-90)
|
41.7 percentage of responders
Interval 33.0 to 50.9
|
10.9 percentage of responders
Interval 5.2 to 21.4
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in HECSI Score
|
-69.9 percentage change
Interval -77.5 to -62.3
|
-31.4 percentage change
Interval -42.2 to -20.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 3 participants in the tralokinumab group and for 1 participant in the placebo group.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=153 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=78 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
|
47.3 percentage of responders
Interval 38.4 to 56.4
|
20.7 percentage of responders
Interval 12.6 to 31.9
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 1 participant in the tralokinumab group and for 1 participant in the placebo group.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=155 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=78 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in HESD Itch Score (Weekly Average)
|
-51.1 percentage change
Interval -56.8 to -45.3
|
-23.7 percentage change
Interval -31.7 to -15.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 18 participants in the tralokinumab group and for 6 participants in the placebo group.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=138 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=73 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
|
45.3 percentage of responders
Interval 36.0 to 55.0
|
13.3 percentage of responders
Interval 7.1 to 23.4
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 3 participants in the tralokinumab group and for 1 participant in the placebo group.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=153 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=78 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in HESD Pain Score (Weekly Average)
|
-60.1 percentage change
Interval -69.1 to -51.1
|
-13.2 percentage change
Interval -25.8 to -0.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
Outcome measures
| Measure |
Tralokinumab
n=154 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=77 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in HEIS Score
|
-64.9 percentage change
Interval -71.1 to -58.7
|
-28.5 percentage change
Interval -37.4 to -19.7
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: FAS. Data is not available for 2 participants in the tralokinumab group and for 2 participants in the placebo group.
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
Outcome measures
| Measure |
Tralokinumab
n=154 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=77 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in DLQI Score
|
-60.9 percentage change
Interval -68.8 to -53.0
|
-21.0 percentage change
Interval -32.1 to -9.9
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: FAS. In the tralokinumab group, data for WPAI:AHE Presenteeism, Absenteeism, and Work Productivity are not available for 48 participants, and data for WPAI+CIQ:AHE Activity impairment are not available for 2 participants. In the placebo group, data for WPAI:AHE Presenteeism and Work Productivity are not available for 25 participants, data for WPAI:AHE Absenteeism are not available for 24 participants, and data for WPAI+CIQ:AHE Activity impairment are not available for 2 participants.
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Presenteeism
|
-29.1 score on a scale
Interval -33.3 to -24.8
|
-12.5 score on a scale
Interval -19.0 to -6.1
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Absenteeism
|
-0.8 score on a scale
Interval -4.5 to 2.9
|
4.2 score on a scale
Interval -1.1 to 9.6
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Work Productivity
|
-26.7 score on a scale
Interval -31.4 to -21.9
|
-10.2 score on a scale
Interval -17.4 to -3.1
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI+CIQ:AHE Activity impairment
|
-36.3 score on a scale
Interval -40.2 to -32.4
|
-15.3 score on a scale
Interval -21.0 to -9.6
|
SECONDARY outcome
Timeframe: At Week 32Population: Analyzed population: FAS
The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab
n=133 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=67 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)
|
77 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: Participants in the FAS (N=156 for tralokinumab group and N=79 for placebo + tralokinumab group) with data at week 32.
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score ranges from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
Outcome measures
| Measure |
Tralokinumab
n=133 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=67 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Participants Having a Decrease in HECSI of at Least 75% (HECSI-75)
|
103 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: Participants in the FAS (N=156 for tralokinumab group and N=79 for placebo + tralokinumab group) with data at week 32.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=124 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=56 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Participants With Reduction in HESD Itch Score (Weekly Average) of ≥4 Points
|
74 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: Participants in the FAS (N=156 for tralokinumab group and N=79 for placebo + tralokinumab group) with data at week 32.
The Hand Eczema Symptom Diary (HESD) is a 6-item patient-reported outcome where the subject assesses the worst severity of 6 individual signs and symptoms of hand eczema over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint assessed only the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Outcome measures
| Measure |
Tralokinumab
n=113 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=51 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Participants With Reduction in HESD Pain Score (Weekly Average) of ≥4 Points
|
84 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: FAS
HEIS: The Hand Eczema Impact Scale (HEIS) includes 9 items addressing the participant's perception of the impact of hand eczema on their daily activities: embarrassment, frustration, sleep, work, and physical functioning over the past 7 days. Each item is scored on a 5-point scale (0='not at all', 1='a little', 2='moderately', 3='a lot', 4='extremely'). The HEIS score is the average of the 9 items.
Outcome measures
| Measure |
Tralokinumab
n=130 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=62 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in HEIS Score
|
-75.65 percentage change
Standard Deviation 29.58
|
-76.16 percentage change
Standard Deviation 31.02
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: FAS
The Dermatology Life Quality Index (DLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
Outcome measures
| Measure |
Tralokinumab
n=129 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=62 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Percentage Change in DLQI Score
|
-72.9 percentage change
Standard Deviation 28.8
|
-73.0 percentage change
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: From baseline to Week 32Population: Analyzed population: FAS
The impact of AHE on the subject's ability to work/school and perform regular activities was assessed by Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire in atopic hand eczema (WPAI+CIQ:AHE), which is an instrument to measure impairments in both paid work and unpaid work/school attendance. Only domain scores where an estimand analysis was possible are presented. Scores are on a scale from 0 to 100 and reflect the percentage impairment due to AHE during the past 7 days, with higher numbers indicating greater impairment and less productivity/school attendance.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Presenteeism
|
-36.35 score on a scale
Standard Deviation 28.78
|
-40.91 score on a scale
Standard Deviation 34.31
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Absenteeism
|
2.09 score on a scale
Standard Deviation 25.65
|
3.33 score on a scale
Standard Deviation 22.44
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI:AHE Work Productivity Loss
|
-31.59 score on a scale
Standard Deviation 29.18
|
-34.97 score on a scale
Standard Deviation 38.36
|
|
Change in WPAI+CIQ:AHE Domain Scores
WPAI+CIQ:AHE Activity impairment
|
-42.48 score on a scale
Standard Deviation 27.78
|
-45.48 score on a scale
Standard Deviation 32.98
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Analyzed population: Safety Analysis Set (SAS): all participants who are exposed to at least 1 dose of IMP.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Outcome measures
| Measure |
Tralokinumab
n=156 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=79 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Treatment-emergent Adverse Events
|
263 events
|
91 events
|
SECONDARY outcome
Timeframe: Week 16 to Week 32Population: Analyzed population: SAS
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Outcome measures
| Measure |
Tralokinumab
n=144 Participants
Tralokinumab was administered for 16 weeks (double-blinded period). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo
n=70 Participants
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
|---|---|---|
|
Number of Treatment-emergent Adverse Events During the Open-label Treatment Period
|
129 events
|
62 events
|
Adverse Events
Tralokinumab DB
Placebo DB
Tralokinumab OL
Serious adverse events
| Measure |
Tralokinumab DB
n=156 participants at risk
Tralokinumab was administered for 16 weeks (double-blinded period \[DB\]). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo DB
n=79 participants at risk
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
Tralokinumab OL
n=214 participants at risk
In the open-label (OL) period, all participants were administered tralokinumab 300 mg (s.c.) every two weeks for 16 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.47%
1/214 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.47%
1/214 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.47%
1/214 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.47%
1/214 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.47%
1/214 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.64%
1/156 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Nervous system disorders
Alcoholic seizure
|
0.64%
1/156 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Vascular disorders
Hypertensive crisis
|
0.64%
1/156 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
1.3%
1/79 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
General disorders
Condition aggrevated
|
0.00%
0/156 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
1.3%
1/79 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
Other adverse events
| Measure |
Tralokinumab DB
n=156 participants at risk
Tralokinumab was administered for 16 weeks (double-blinded period \[DB\]). After a loading dose of 600 mg under the skin (s.c.) at baseline, trial participants were administered a dose of 300 mg (s.c.) every two weeks for 16 weeks.
|
Placebo DB
n=79 participants at risk
Placebo was administered for 16 weeks (double-blinded period). After a loading dose under the skin (s.c.) at baseline, trial participants were administered a placebo dose (s.c.) every two weeks for 16 weeks.
|
Tralokinumab OL
n=214 participants at risk
In the open-label (OL) period, all participants were administered tralokinumab 300 mg (s.c.) every two weeks for 16 weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
1.3%
2/156 • Number of events 2 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
8.9%
7/79 • Number of events 7 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
General disorders
Injection site reaction
|
6.4%
10/156 • Number of events 19 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
1.3%
1/79 • Number of events 1 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
7.9%
17/214 • Number of events 30 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Infections and infestations
COVID-19
|
5.1%
8/156 • Number of events 8 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/79 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
26/156 • Number of events 38 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
7.6%
6/79 • Number of events 6 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
7.5%
16/214 • Number of events 19 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
6/156 • Number of events 9 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
5.1%
4/79 • Number of events 4 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.8%
9/156 • Number of events 11 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
5.1%
4/79 • Number of events 7 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
0.00%
0/214 • Treatment emergent adverse events were collected during the 32 weeks of treatment + 4 weeks of follow-up.
An event was considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER