Trial Outcomes & Findings for Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 (NCT NCT03761537)

Last Updated: 2025-03-11

Results Overview

EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. 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

PHASE3

Target enrollment

277 participants

Primary outcome timeframe

Week 0 to Week 16

Results posted on

2025-03-11

Participant Flow

After the participant gave informed consent, they went through a 2- to 6-week screening period. Eligibility was assessed at the (first) screening visit and on Day 0 (hereinafter "baseline") prior to randomisation.

Participant milestones

Participant milestones
Measure	Tralokinumab + TCS Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.	Placebo + TCS Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.
Overall Study STARTED	140	137
Overall Study COMPLETED	125	120
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of participants analysed is different from the number of participants randomised due to missing data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tralokinumab + TCS n=140 Participants Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.	Placebo + TCS n=137 Participants Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.	Total n=277 Participants Total of all reporting groups
Age, Continuous	33.0 Years n=140 Participants	34.0 Years n=137 Participants	34.0 Years n=277 Participants
Age, Customized 18-64	134 Participants n=140 Participants	131 Participants n=137 Participants	265 Participants n=277 Participants
Age, Customized 65-84	6 Participants n=140 Participants	6 Participants n=137 Participants	12 Participants n=277 Participants
Sex: Female, Male Female	58 Participants n=140 Participants	54 Participants n=137 Participants	112 Participants n=277 Participants
Sex: Female, Male Male	82 Participants n=140 Participants	83 Participants n=137 Participants	165 Participants n=277 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=140 Participants	4 Participants n=137 Participants	10 Participants n=277 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants n=140 Participants	133 Participants n=137 Participants	267 Participants n=277 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=140 Participants	0 Participants n=137 Participants	0 Participants n=277 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=140 Participants	0 Participants n=137 Participants	0 Participants n=277 Participants
Race (NIH/OMB) Asian	0 Participants n=140 Participants	1 Participants n=137 Participants	1 Participants n=277 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=140 Participants	0 Participants n=137 Participants	1 Participants n=277 Participants
Race (NIH/OMB) Black or African American	0 Participants n=140 Participants	1 Participants n=137 Participants	1 Participants n=277 Participants
Race (NIH/OMB) White	137 Participants n=140 Participants	135 Participants n=137 Participants	272 Participants n=277 Participants
Race (NIH/OMB) More than one race	0 Participants n=140 Participants	0 Participants n=137 Participants	0 Participants n=277 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=140 Participants	0 Participants n=137 Participants	2 Participants n=277 Participants
Region of Enrollment Belgium	25 Participants n=140 Participants	27 Participants n=137 Participants	52 Participants n=277 Participants
Region of Enrollment Czechia	14 Participants n=140 Participants	12 Participants n=137 Participants	26 Participants n=277 Participants
Region of Enrollment Poland	34 Participants n=140 Participants	43 Participants n=137 Participants	77 Participants n=277 Participants
Region of Enrollment United Kingdom	5 Participants n=140 Participants	9 Participants n=137 Participants	14 Participants n=277 Participants
Region of Enrollment France	12 Participants n=140 Participants	7 Participants n=137 Participants	19 Participants n=277 Participants
Region of Enrollment Germany	22 Participants n=140 Participants	18 Participants n=137 Participants	40 Participants n=277 Participants
Region of Enrollment Spain	28 Participants n=140 Participants	21 Participants n=137 Participants	49 Participants n=277 Participants
Age at onset of atopic dermatitis	2.5 Years n=140 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	3.0 Years n=136 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	3.0 Years n=276 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Duration of atopic dermatitis	26.0 Years n=140 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	25.0 Years n=136 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	26.0 Years n=276 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Body surface area with atopic dermatitis	52.0 Percentage affected n=140 Participants	52.0 Percentage affected n=137 Participants	52.0 Percentage affected n=277 Participants
Investigator's Global Assessment (IGA) Moderate Disease	68 Participants n=138 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	70 Participants n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	138 Participants n=275 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Investigator's Global Assessment (IGA) Severe Disease	70 Participants n=138 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	67 Participants n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	137 Participants n=275 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Eczema Area and Severity Index (EASI)	28.60 Units on a scale n=138 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	29.10 Units on a scale n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	28.80 Units on a scale n=275 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Scoring Atopic Dermatitis (SCORAD)	69.20 Units on a scale n=138 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	68.90 Units on a scale n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	69.10 Units on a scale n=275 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Dermatology Life Quality Index (DLQI)	16.00 Units on a scale n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	16.00 Units on a scale n=134 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	16.00 Units on a scale n=271 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.
Worst Daily Pruritus numeric rating scale (NRS) (weekly average)	7.43 Units on a scale n=137 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	7.50 Units on a scale n=136 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.	7.43 Units on a scale n=273 Participants • The number of participants analysed is different from the number of participants randomised due to missing data.

PRIMARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set (FAS). Of the 277 participants randomised to initial treatment, 275 were treated. Therefore, the FAS consisted of 275 participants (138 participants in the tralokinumab+TCS group + 137 participants in the placebo+TCS group).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16	64.2 Percentage of responders	50.5 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).

Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=134 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=135 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16	45.5 Percentage of responders	35.6 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set (FAS).

SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16	-42.7 Units on a scale Standard Error 1.6	-34.1 Units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full Set Analysis (FAS).

DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=134 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16	-11.2 Units on a scale Standard Error 0.4	-9.6 Units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS).

IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	40.9 Percentage of responders	26.0 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Full analysis set (FAS).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26	68.8 Percentage of responders	55.3 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).

Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=134 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=135 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26	47.2 Percentage of responders	39.7 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Full analysis set (FAS).

SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26	-46.3 Units on a scale Standard Error 1.5	-37.3 Units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Full Set Analysis (FAS).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=134 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26	-11.5 Units on a scale Standard Error 0.4	-9.9 Units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Week 26

Population: Full analysis set (FAS).

IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26	47.0 Percentage of responders	33.4 Percentage of responders

SECONDARY outcome

Timeframe: Week 0 to Week 40

Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40 Positive	2 Participants	3 Participants
Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40 Negative	134 Participants	133 Participants
Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40 Perishing	1 Participants	1 Participants
Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40 No post-baseline ADA assessment	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 40

All adverse events are presented below under Adverse Events

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=138 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	Placebo+TCS n=137 Participants Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
Number of Adverse Events From Week 0 to Week 40	389 number of adverse events	435 number of adverse events

Adverse Events

Treatment Period: Tralokinumab+TCS

Serious events: 1 serious events

Other events: 107 other events

Deaths: 0 deaths

Treatment Period: Placebo+TCS

Serious events: 5 serious events

Other events: 108 other events

Deaths: 0 deaths

Safety Follow-up Period: Tralokinumab+TCS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Safety Follow-up Period: Placebo+TCS

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Period: Tralokinumab+TCS n=138 participants at risk Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24. For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.	Treatment Period: Placebo+TCS n=137 participants at risk Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24. For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.	Safety Follow-up Period: Tralokinumab+TCS n=75 participants at risk Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND). For the safety follow-up period, all AEs will be reported.	Safety Follow-up Period: Placebo+TCS n=83 participants at risk Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND). For the safety follow-up period, all AEs will be reported.
Infections and infestations Appendicitis	0.72% 1/138 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/137 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Nervous system disorders Cerebrovascular accident	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Nervous system disorders Seizure	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Immune system disorders Anaphylactic reaction	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Injury, poisoning and procedural complications Peripheral nerve injury	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Psychiatric disorders Depressed mood	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Psychiatric disorders Suicidal ideation	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.73% 1/137 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/83 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.
Infections and infestations Pyelonephritis	0.00% 0/138 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/137 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	0.00% 0/75 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.	1.2% 1/83 • Number of events 1 • Treatment period (Week 0 to Week 26), safety follow-up period (Week 26 to Week 40). The analysis was conducted based on the safety analysis set which consisted of subjects exposed to at least 1 dose of investigational medicinal product (IMP e.g., tralokinumab or placebo). In the category Other adverse events (AEs), all AEs will be reported in the safety follow-up period, whereas a frequency threshold at 2% AEs will apply for the treatment period, except that all AEs will be reported if also part of the safety follow-up period.

Other adverse events

Additional Information

Disclosure

LEO Pharma A/S

Phone: 44 94 58 88

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place