Trial Outcomes & Findings for Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis (NCT NCT04587453)

Last Updated: 2025-03-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

Week 16

Results posted on

2025-03-11

Participant Flow

First subject first visit: 27-Oct-2020. Subjects were recruited at 25 sites in Japan.

126 subjects were screened. 20 subjects were screening failures. 106 subjects were included in the trial and randomised 1:1 to tralokinumab+TCS and placebo+TCS. All randomised subjects received at least 1 dose of investigational medicinal product (IMP).

Participant milestones

Participant milestones
Measure	Tralokinumab+TCS Treatment period (Week 0 to Week 16): Participants received 600 mg tralokinumab (4 subcutaneous injections) as a loading dose on Day 0. Then they received 300 mg tralokinumab (2 subcutaneous injections) every 2 weeks until Week 14. Topical corticosteroids (TCS) (mometasone furoate, 0.1% cream, Japan classification: Very strong) were applied on the skin as needed. Safety follow-up period (Week 17 to Week 20): Period without treatment. Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.	Placebo+TCS Treatment period (Week 0 to Week 16): Participants received 4 subcutaneous injections of placebo (resembling a loading dose) on Day 0. Then they received 2 subcutaneous injections of placebo every 2 weeks until Week 14. Topical corticosteroids (TCS) (mometasone furoate, 0.1% cream, Japan classification: Very strong) were applied on the skin as needed. Safety follow-up period (Week 17 to Week 20): Period without treatment. Placebo contains the same excipients in the same concentration, but without the active ingredient of tralokinumab.
Treatment Period (Week 0 to Week 16) STARTED	53	53
Treatment Period (Week 0 to Week 16) Full Analysis Set	53	53
Treatment Period (Week 0 to Week 16) Safety Analysis Set	53	53
Treatment Period (Week 0 to Week 16) COMPLETED	53	52
Treatment Period (Week 0 to Week 16) NOT COMPLETED	0	1
Safety Follow-up (Week 16 to Week 20) STARTED	8	3
Safety Follow-up (Week 16 to Week 20) Not Started	45	49
Safety Follow-up (Week 16 to Week 20) Safety Follow-up Analysis Set	8	4
Safety Follow-up (Week 16 to Week 20) COMPLETED	8	3
Safety Follow-up (Week 16 to Week 20) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tralokinumab+TCS Treatment period (Week 0 to Week 16): Participants received 600 mg tralokinumab (4 subcutaneous injections) as a loading dose on Day 0. Then they received 300 mg tralokinumab (2 subcutaneous injections) every 2 weeks until Week 14. Topical corticosteroids (TCS) (mometasone furoate, 0.1% cream, Japan classification: Very strong) were applied on the skin as needed. Safety follow-up period (Week 17 to Week 20): Period without treatment. Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.	Placebo+TCS Treatment period (Week 0 to Week 16): Participants received 4 subcutaneous injections of placebo (resembling a loading dose) on Day 0. Then they received 2 subcutaneous injections of placebo every 2 weeks until Week 14. Topical corticosteroids (TCS) (mometasone furoate, 0.1% cream, Japan classification: Very strong) were applied on the skin as needed. Safety follow-up period (Week 17 to Week 20): Period without treatment. Placebo contains the same excipients in the same concentration, but without the active ingredient of tralokinumab.
Treatment Period (Week 0 to Week 16) Premature (before Week 16) discontinuation of IMP	0	1

Baseline Characteristics

Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	53 Participants n=7 Participants	105 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	39.0 years STANDARD_DEVIATION 13.7 • n=5 Participants	38.9 years STANDARD_DEVIATION 12.1 • n=7 Participants	39.0 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Age at onset of atopic dermatitis	3.0 years n=5 Participants	5.0 years n=7 Participants	4.0 years n=5 Participants
Duration of atopic dermatitis	32.0 years STANDARD_DEVIATION 13.0 • n=5 Participants	30.8 years STANDARD_DEVIATION 14.0 • n=7 Participants	31.4 years STANDARD_DEVIATION 13.5 • n=5 Participants
Body surface area (BSA) with atopic dermatitis	66.6 percentage of BSA affected STANDARD_DEVIATION 20.7 • n=5 Participants	64.4 percentage of BSA affected STANDARD_DEVIATION 18.5 • n=7 Participants	65.5 percentage of BSA affected STANDARD_DEVIATION 19.6 • n=5 Participants
Investigator's Global Assessment (IGA) Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Investigator's Global Assessment (IGA) Almost clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Investigator's Global Assessment (IGA) Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Investigator's Global Assessment (IGA) Moderate	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Investigator's Global Assessment (IGA) Severe	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Eczema Area and Severity Index (EASI) score	37.12 score on a scale STANDARD_DEVIATION 15.71 • n=5 Participants	32.30 score on a scale STANDARD_DEVIATION 12.32 • n=7 Participants	34.71 score on a scale STANDARD_DEVIATION 14.25 • n=5 Participants
Scoring Atopic Dermatitis (SCORAD)	71.72 score on a scale STANDARD_DEVIATION 13.79 • n=5 Participants	69.82 score on a scale STANDARD_DEVIATION 12.39 • n=7 Participants	70.77 score on a scale STANDARD_DEVIATION 13.08 • n=5 Participants
Dermatology Life Quality Index (DLQI)	13.09 score on a scale STANDARD_DEVIATION 6.92 • n=5 Participants	14.30 score on a scale STANDARD_DEVIATION 6.39 • n=7 Participants	13.70 score on a scale STANDARD_DEVIATION 6.65 • n=5 Participants
Worst Daily Pruritus numeric rating scale (NRS)	7.60 score on a scale STANDARD_DEVIATION 1.65 • n=5 Participants	7.81 score on a scale STANDARD_DEVIATION 1.37 • n=7 Participants	7.71 score on a scale STANDARD_DEVIATION 1.51 • n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

IGA is an instrument used in clinical trials to rate the severity of the participant'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=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	17 Participants	14 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16	38 Participants	30 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

SCORAD is a validated tool to evaluate the AD disease based on 3 components: * A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%). * B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18). * C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20). The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16	-44.1 change in score on a scale Standard Error 2.61	-39.0 change in score on a scale Standard Error 2.61

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past 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 (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.	-10.0 change in score on a scale Standard Error 0.56	-8.8 change in score on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16	34 Participants	36 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
At Least 90% Reduction in EASI (EASI90) at Week 16	24 Participants	16 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
At Least 50% Reduction in EASI (EASI50) at Week 16	45 Participants	42 Participants

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=49 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Percentage Change in EASI Score From Baseline to Week 16	-77.8 percentage change in score on a scale Standard Error 3.70	-73.5 percentage change in score on a scale Standard Error 3.76

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set:106 subjects, all randomised and treated.

Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=49 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16	-4.6 change in score on a scale Standard Error 0.26	-4.6 change in score on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered').

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=49 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16	-4.2 change in score on a scale Standard Error 0.25	-4.1 change in score on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Full analysis set: 106 subjects, all randomised and treated.

POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=49 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16	-14.4 change in score on a scale Standard Error 0.82	-11.2 change in score on a scale Standard Error 0.83

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.

Number of events divided by patient years of exposure (= rate).

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject	605.9 events per patient year of exposure	332.8 events per patient year of exposure

SECONDARY outcome

Timeframe: Week 0 to Week 16

Population: Safety analysis set. Included all subjects exposed to IMP at least 1 time.

Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative.

Outcome measures

Outcome measures
Measure	Tralokinumab+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Placebo+TCS n=53 Participants Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.
Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16	0 participants with treatment-emergent ADA	0 participants with treatment-emergent ADA

Adverse Events

Treatment Period: Tralokinumab+TCS

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Treatment Period: Placebo+TCS

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Safety Follow-up Period: Tralokinumab+TCS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Safety Follow-up Period: Placebo+TCS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Disclosure

Leo Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
Publication restrictions are in place

Restriction type: OTHER

Measure	Treatment Period: Tralokinumab+TCS n=53 participants at risk During the treatment period (Week 0 to Week 16), participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed.	Treatment Period: Placebo+TCS n=53 participants at risk During the treatment period (Week 0 to Week 16), participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed.	Safety Follow-up Period: Tralokinumab+TCS n=8 participants at risk No treatment was administered during the safety-follow-up period (Week 17 to Week 20). Participants received tralokinumab+TCS in the treatment period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).	Safety Follow-up Period: Placebo+TCS n=4 participants at risk No treatment was administered during the safety-follow-up period (Week 17 to Week 20). Participants received placebo+TCS in the treatment period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND).
Gastrointestinal disorders Constipation	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Gastrointestinal disorders Gastritis	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
General disorders Injection site erythema	5.7% 3/53 • Number of events 12 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
General disorders Injection site reaction	9.4% 5/53 • Number of events 10 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
General disorders Pyrexia	5.7% 3/53 • Number of events 3 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	12.5% 1/8 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Immune system disorders Seasonal allergy	5.7% 3/53 • Number of events 3 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Infections and infestations Cellulitis	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Infections and infestations Hordeolum	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Infections and infestations Nasopharyngitis	5.7% 3/53 • Number of events 4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	9.4% 5/53 • Number of events 6 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Infections and infestations Oral herpes	1.9% 1/53 • Number of events 3 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	12.5% 1/8 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Infections and infestations Paronychia	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	25.0% 1/4 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Musculoskeletal and connective tissue disorders Back pain	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	1.9% 1/53 • Number of events 1 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Nervous system disorders Presyncope	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Skin and subcutaneous tissue disorders Acne	11.3% 6/53 • Number of events 7 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	7.5% 4/53 • Number of events 4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/53 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.
Skin and subcutaneous tissue disorders Urticaria	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	3.8% 2/53 • Number of events 2 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/8 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.	0.00% 0/4 • Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 20 Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time.