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Clinical Trial Results:
A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 6 (ECZema TRAlokinumab trial no.6)

Summary
EudraCT number	2017-005143-33
Trial protocol	FR PL DE NL BE GB
Global end of trial date	16 Mar 2021

Results information
Results version number	v2(current)
This version publication date	20 Jul 2022
First version publication date	01 Oct 2021
Other versions	v1
Version creation reason	Correction of full data set Error corrected.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

LP0162-1334

ISRCTN number

US NCT number

NCT03526861

WHO universal trial number (UTN)

Sponsor organisation name

LEO Pharma A/S

Sponsor organisation address

Industriparken 55, Ballerup, Denmark, 2750

Public contact

Clinical Disclosure Specialist, LEO Pharma A/S , +45 44945888, disclosure@leo-pharma.com

Scientific contact

Clinical Disclosure Specialist, LEO Pharma A/S , +45 44945888, disclosure@leo-pharma.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001900-PIP02-17

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

12 May 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

16 Mar 2021

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of subcutaneous administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe atopic dermatitis.

Protection of trial subjects

This clinical trial was conducted to conform to the principles of the Declaration of Helsinki as adopted by the 18th World Medical Association General Assembly, 1964, and subsequent amendments. Subjects and their legally acceptable representative received written and verbal information concerning the clinical trial and were given an opportunity to ask questions and sufficient time to consider before consenting. Subjects not of legal age assented to participation in the trial, and for such subjects, one or more legally authorised representatives provided consent. Subjects or legally authorised representatives were asked to consent to their personal data being recorded, collected, processed and transferred to EU and non-EU countries in accordance with any national legislation regulating privacy and data protection. Some subjects were randomised to initial treatment with placebo, and subjects who achieved a clinical response at Week 16 with placebo were assigned to continue placebo treatment until Week 52. If medically necessary (i.e. to control intolerable atopic dermatitis [AD] symptoms), rescue treatment for AD could be provided to subjects throughout the trial, both during the initial treatment period and the maintenance treatment period, at the discretion of the investigator. For the first 3 investigational medicinal product (IMP) dosing visits in both the initial treatment period (i.e. Weeks 0, 2, and 4) and in open-label treatment, subjects were monitored after IMP administration for immediate drug reactions for a minimum of 2 hours with vital signs taken every 30 minutes or until stable, whichever was later. Vital signs were documented in the electronic case report forms. Appropriate drugs, such as epinephrine, antihistamines, corticosteroids, etc., and medical equipment to treat acute anaphylactic reactions were immediately available at trial sites, and trial personnel was trained to recognise and respond to anaphylaxis according to local guidelines

Background therapy

All subjects were to use an emollient twice daily (or more, as needed) for at least 14 days before randomisation and were to continue this treatment throughout the trial.

Evidence for comparator

Actual start date of recruitment

13 Jul 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 105

Country: Number of subjects enrolled

Canada: 52

Country: Number of subjects enrolled

Australia: 14

Country: Number of subjects enrolled

Japan: 32

Country: Number of subjects enrolled

Netherlands: 13

Country: Number of subjects enrolled

Poland: 54

Country: Number of subjects enrolled

United Kingdom: 4

Country: Number of subjects enrolled

Belgium: 8

Country: Number of subjects enrolled

France: 8

Country: Number of subjects enrolled

Germany: 11

Worldwide total number of subjects

301

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

301

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Trial start date: 13-Jul-2018. Primary completion date: 15-Apr-2020, Trial completion date: March 16 2021. The trial was conducted in 10 countries: United States, Australia, Canada, United Kingdom, Poland, Belgium, Germany, France, Japan, and the Netherlands.

Screening details

The screening period was 2 to 6 weeks and included 1 or 2 visits. The exact duration depended on the washout period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomisation.

Period 1 title

Initial treatment period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

This was a double-blind trial in which tralokinumab and placebo were visually distinct from each other. The IMP was handled and administered by a qualified, unblinded healthcare professional (HCP) at the site who was not involved in the management of trial subjects and who did not perform any of the assessments.

Are arms mutually exclusive

Yes

Initial treatment period - Tralokinumab 300 mg Q2W

Arm description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 300 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Initial treatment period - Tralokinumab 150 mg Q2W

Arm description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 150 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 1 SC injection (1.0 mL) of 150 mg tralokinumab and 1 SC injection (1.0 mL) of placebo to receive a total dose of 150 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Initial treatment period - Placebo Q2W

Arm description

Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).

Arm type

Placebo

Investigational medicinal product name

Placebo Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Number of subjects in period 1	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Started	101	100	100
Completed	94	93	86
Not completed	7	7	14
Excluded from trial+FAS due to quality/GCP issues	3	1	5
Discontinued IMP before Week 16	3	5	8
Not dosed	1	1	1

Period 2 title

Open-label treatment period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS

Arm description

Subjects in the open-label treatment period (Week 16 to Week 52) treated with tralokinumab every second week (Q2W) + optional TCS. Subjects transferred to open-label treatment at Week 16 if they did not achieve protocol-defined clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 OR after Week 16 if they lost clinical response during the maintenance treatment period. Loss of clinical response during the maintenance treatment period was defined as: -IGA of at least 2 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=0 at Week 16 -IGA of at least 3 and not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA=1 at Week 16 -Not achieving EASI75 over at least a 4-week period (3 consecutive visits) for subjects with IGA>1 at Week 1

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 300 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg. IMP was administered by a qualified HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Number of subjects in period 2 ^[1]	Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS
Started	242
Completed	214
Not completed	28
Excluded from trial+FAS due to quality/GCP issues	8
Discontinued IMP before Week 52	19
Received IMP and withdrew from trial at Week 50	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The open-label treatment period was in parallel to the maintenance treatment period. Subjects from the initial treatment period entered either into the open-label treatment period or maintenance treatment period.

Period 3 title

Maintenance treatment period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

This was a double-blind trial in which tralokinumab and placebo were visually distinct from each other. The IMP was handled and administered by a qualified, unblinded HCP at the site who was not involved in the management of trial subjects and who did not perform any of the assessments. Maintenance treatment period was in parallel to the Open-label treatment period.

Are arms mutually exclusive

Yes

Maintenance Treatment Period - Tralokinumab 300 mg Q2W

Arm description

Subjects initially randomised to tralokinumab 300 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 300 mg Q2W maintenance treatment.

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 300 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Maintenance Treatment Period - Tralokinumab 300 mg Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 300 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received alternating dose administrations: 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab or 2 subcutaneous injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Maintenance Treatment Period - Tralokinumab 150 mg Q2W

Arm description

Subjects initially randomised to tralokinumab 150 mg Q2W, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-randomised to tralokinumab 150 mg Q2W maintenance treatment.

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 150 mg Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo Q2W to receive a total dose of 150 mg tralokinumab. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Maintenance Treatment Period - Tralokinumab 150 mg Q4W

Arm description

Arm type

Experimental

Investigational medicinal product name

Tralokinumb 150 mg Q4W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received alternating dose administrations: 1 subcutaneous injection (1.0 mL) of 150 mg tralokinumab and 1 subcutaneous injection (1.0 mL) of placebo to receive a total dose of 300 mg tralokinumab or 2 subcutaneous injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the subcutaneous tissue of the upper arm, anterior thigh, or abdomen.

Maintenance Treatment Period - Placebo Q2W

Arm description

Subjects initially randomised to placebo, achieving a clinical response (defined as Investigator's Global Assessment score of 0 or 1, or at least 75% reduction in Eczema Area and Severity Index) at Week 16 without use of rescue medication from Week 2 to Week 16, and re-assigned to placebo maintenance treatment.

Arm type

Experimental

Investigational medicinal product name

Placebo Q2W

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

At each visit, subject received 2 SC injections (each 1.0 mL) of placebo. IMP was administered by a qualified, unblinded HCP. The injections were administered into the SC tissue of the upper arm, anterior thigh, or abdomen, separated by at least 3 cm.

Number of subjects in period 3 ^[2]	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Maintenance Treatment Period - Tralokinumab 150 mg Q2W	Maintenance Treatment Period - Tralokinumab 150 mg Q4W	Maintenance Treatment Period - Placebo Q2W
Started	13	14	12	14	6
Completed	5	8	8	8	4
Not completed	8	6	4	6	2
Transferred to open-label treatment	6	5	4	5	2
Excluded from trial+FAS due to quality/GCP issues	1	-	-	-	-
Discontinued IMP before Week 52	1	1	-	1	-

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The maintenance treatment period was in parallel to the open-label treatment period. Subjects from the initial treatment phase entered either into the maintenance treatment period or the open-label treatment period.

Baseline characteristics

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Reporting group title

Initial treatment period - Tralokinumab 300 mg Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)

Reporting group title

Initial treatment period - Tralokinumab 150 mg Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)

Reporting group title

Initial treatment period - Placebo Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).

Reporting group values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W	Total
Number of subjects	101	100	100	301
Age categorical
Units: Subjects
Adolescents (12-17 years)	101	100	100	301
Age continuous
Units: years
arithmetic mean (standard deviation)	14.6 ± 1.8	14.8 ± 1.7	14.4 ± 1.6	-
Gender categorical
Units: Subjects
Female	52	48	46	146
Male	49	52	54	155
Race
Units: Subjects
White	59	56	58	173
Black or African American	14	8	12	34
Asian	21	28	23	72
American Indian or Alaska native	0	2	1	3
Native Hawaiian or other Pacific islander	2	0	2	4
Other	5	6	4	15
Ethnicity
Units: Subjects
Hispanic or Latino	12	10	10	32
Not Hispanic or Latino	89	90	90	269
Unknown or Not Reported	0	0	0	0
Investigator's Global Assessment
The Investigator's Global Assessment (IGA) is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Units: Subjects
Clear	0	0	0	0
Almost Clear	0	0	0	0
Mild	0	0	0	0
Moderate	52	55	54	161
Severe	48	44	45	137
Missing	1	1	1	3
Eczema Area and Severity Index
Measure description: The Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Units: Units on a scale
arithmetic mean (standard deviation)	31.90 ± 13.74	31.89 ± 12.97	31.25 ± 14.19	-
Scoring Atopic Dermatitis
The Scoring Atopic Dermatitis (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.
Units: Units on a scale
arithmetic mean (standard deviation)	68.41 ± 13.51	67.42 ± 14.51	67.70 ± 14.77	-
Children's Dermatology Life Quality Index
The Children's Dermatology Life Quality Index (CDLQI) consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite 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 health-related quality of life.
Units: units on a scale
arithmetic mean (standard deviation)	13.29 ± 7.18	12.86 ± 6.27	13.14 ± 5.99	-
Adolescent Worst Pruritus NRS (weekly average)
Subjects assessed their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Adolescent Worst Pruritus NRS') each morning, with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
Units: units on a scale
arithmetic mean (standard deviation)	7.79 ± 1.53	7.49 ± 1.58	7.45 ± 1.62	-
Body surface area affected by atopic dermatitis (AD)
Units: percentage affected
arithmetic mean (standard deviation)	49.8 ± 23.0	52.0 ± 22.5	50.9 ± 23.5	-
Age of onset of atopic dermatitis (AD)
Units: years
arithmetic mean (standard deviation)	2.5 ± 3.5	2.1 ± 3.3	2.4 ± 3.5	-
Duration of atopic dermatitis (AD)
Units: years
arithmetic mean (standard deviation)	12.1 ± 3.7	12.7 ± 3.7	12.0 ± 3.4	-

End points

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Reporting group title

Initial treatment period - Tralokinumab 300 mg Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 300 mg every second week (Q2W)

Reporting group title

Initial treatment period - Tralokinumab 150 mg Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with tralokinumab 150 mg every second week (Q2W)

Reporting group title

Initial treatment period - Placebo Q2W

Reporting group description

Subjects in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W).

Reporting group title

Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 300 mg Q2W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 300 mg Q4W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 150 mg Q2W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 150 mg Q4W

Reporting group description

Reporting group title

Maintenance Treatment Period - Placebo Q2W

Reporting group description

Primary: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

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End point title

Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

End point description

The 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).

End point type

Primary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	17	21	4

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.002 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

13.8

Confidence interval

level

95%

sides

2-sided

lower limit

5.3

upper limit

22.3

Notes
[1] - Primary endpoint tested sequentially at a 5% significance level.
[2] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

< 0.001 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

17.5

Confidence interval

level

95%

sides

2-sided

lower limit

8.4

upper limit

26.6

Notes
[3] - Primary endpoint tested sequentially at a 5% significance level.
[4] - Based on the primary analysis of the primary estimand 'composite'.

Primary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

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End point title

Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

End point description

The EASI 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.

End point type

Primary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	27	28	6

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

> 0.001 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Notes
[5] - Primary endpoint tested sequentially at a 5% significance level.
[6] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

22.5

Confidence interval

level

95%

sides

2-sided

lower limit

12.4

upper limit

32.6

Notes
[7] - Primary endpoint tested sequentially at a 5% significance level.
[8] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

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End point title

Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

End point description

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	96 ^[9]	95 ^[10]	90 ^[11]
Units: Number of subjects with response	24	22	3

Notes
[9] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.
[10] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.
[11] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4.

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

186

Analysis specification

Pre-specified

Analysis type

superiority ^[12]

P-value

< 0.001 ^[13]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

21.7

Confidence interval

level

95%

sides

2-sided

lower limit

12.3

upper limit

31.1

Notes
[12] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
[13] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

185

Analysis specification

Pre-specified

Analysis type

superiority ^[14]

P-value

< 0.001 ^[15]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

19.9

Confidence interval

level

95%

sides

2-sided

lower limit

10.6

upper limit

29.2

Notes
[14] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
[15] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16

Top of page

End point title

Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16

End point description

The 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.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	98	97	94
Units: Adjusted mean change
least squares mean (standard error)	-29.1 ± 2.4	-27.5 ± 2.4	-9.5 ± 3.0

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[16]

P-value

< 0.001 ^[17]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-19.7

Confidence interval

level

95%

sides

2-sided

lower limit

-27.1

upper limit

-12.2

Notes
[16] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
[17] - Based on the primary analysis of the primary estimand 'hypothetical'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[18]

P-value

< 0.001 ^[19]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-18

Confidence interval

level

95%

sides

2-sided

lower limit

-25.6

upper limit

-10.4

Notes
[18] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
[19] - Based on the primary analysis of the primary estimand 'hypothetical'.

Secondary: Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

Top of page

End point title

Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

End point description

The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	94 ^[20]	95 ^[21]	89 ^[22]
Units: Adjusted mean change
least squares mean (standard error)	-6.7 ± 0.6	-6.1 ± 0.6	-4.1 ± 0.7

Notes
[20] - Subjects in the full analysis set with non-missing baseline CDLQI score
[21] - Subjects in the full analysis set with non-missing baseline CDLQI score
[22] - Subjects in the full analysis set with non-missing baseline CDLQI score

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

183

Analysis specification

Pre-specified

Analysis type

superiority ^[23]

P-value

= 0.007 ^[24]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

-0.7

Notes
[23] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints.
[24] - Based on the primary analysis of the primary estimand 'hypothetical'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

184

Analysis specification

Pre-specified

Analysis type

superiority ^[25]

P-value

= 0.04 ^[26]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

-0.1

Notes
[25] - This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints.
[26] - Based on the primary analysis of the primary estimand 'hypothetical'.

Secondary: Number of Adverse Events

Top of page

End point title

Number of Adverse Events

End point description

Overall number of AEs during the Initial treatment period is presented. For a complete description of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the initial treatment period, maintenance treatment period, open-label treatment period, and safety follow-up period, see the Adverse Events Overview section.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of adverse events	130	175	134

No statistical analyses for this end point

Secondary: Presence of Anti-drug Antibodies

Top of page

End point title

Presence of Anti-drug Antibodies

End point description

Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects	1	7	2

No statistical analyses for this end point

Secondary: Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.

Top of page

End point title

Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.

End point description

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	50	45	13

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[27]

P-value

< 0.001 ^[28]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

38.5

Confidence interval

level

95%

sides

2-sided

lower limit

26.8

upper limit

50.2

Notes
[27] - The statistical test was not controlled for multiplicity.
[28] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[29]

P-value

< 0.001 ^[30]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

32.4

Confidence interval

level

95%

sides

2-sided

lower limit

20.6

upper limit

44.1

Notes
[29] - The statistical test was not controlled for multiplicity.
[30] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.

Top of page

End point title

Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.

End point description

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	17	19	4

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[31]

P-value

= 0.002 ^[32]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

13.7

Confidence interval

level

95%

sides

2-sided

lower limit

5.2

upper limit

22.2

Notes
[31] - The statistical test was not controlled for multiplicity.
[32] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[33]

P-value

< 0.001 ^[34]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

15.3

Confidence interval

level

95%

sides

2-sided

lower limit

6.5

upper limit

24.1

Notes
[33] - The statistical test was not controlled for multiplicity.
[34] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16

Top of page

End point title

Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Adjusted mean change
least squares mean (standard error)	-18.1 ± 1.3	-18.1 ± 1.4	-8.7 ± 1.6

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[35]

P-value

< 0.001 ^[36]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-9.4

Confidence interval

level

95%

sides

2-sided

lower limit

-13.5

upper limit

-5.3

Notes
[35] - The statistical test was not controlled for multiplicity.
[36] - Based on the primary analysis of the primary estimand 'hypothetical'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[37]

P-value

< 0.001 ^[38]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-9.4

Confidence interval

level

95%

sides

2-sided

lower limit

-13.6

upper limit

-5.3

Notes
[37] - The statistical test was not controlled for multiplicity.
[38] - Based on the primary analysis of the primary estimand 'hypothetical'.

Secondary: Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16

Top of page

End point title

Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16

End point description

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	12	16	1

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[39]

P-value

= 0.002 ^[40]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

11.5

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

18.4

Notes
[39] - The statistical test was not controlled for multiplicity.
[40] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[41]

P-value

< 0.001 ^[42]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

15.6

Confidence interval

level

95%

sides

2-sided

lower limit

7.8

upper limit

23.3

Notes
[41] - The statistical test was not controlled for multiplicity.
[42] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16

Top of page

End point title

Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16

End point description

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	97	98	94
Units: Number of subjects with response	30	30	5

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

191

Analysis specification

Pre-specified

Analysis type

superiority ^[43]

P-value

< 0.001 ^[44]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

26.2

Confidence interval

level

95%

sides

2-sided

lower limit

16.1

upper limit

36.3

Notes
[43] - The statistical test was not controlled for multiplicity.
[44] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

192

Analysis specification

Pre-specified

Analysis type

superiority ^[45]

P-value

< 0.001 ^[46]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

25.5

Confidence interval

level

95%

sides

2-sided

lower limit

15.3

upper limit

35.7

Notes
[45] - The statistical test was not controlled for multiplicity.
[46] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16

Top of page

End point title

Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16

End point description

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	96 ^[47]	96 ^[48]	92 ^[49]
Units: Adjusted mean change
least squares mean (standard error)	-3.0 ± 0.3	-2.7 ± 0.3	-1.5 ± 0.3

Notes
[47] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.
[48] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.
[49] - Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score.

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

superiority ^[50]

P-value

< 0.001 ^[51]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

-0.6

Notes
[50] - The statistical test was not controlled for multiplicity.
[51] - Based on the primary analysis of the primary estimand 'hypothetical'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

superiority ^[52]

P-value

= 0.007 ^[53]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

-0.3

Notes
[52] - The statistical test was not controlled for multiplicity.
[53] - Based on the primary analysis of the primary estimand 'hypothetical'.

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16

Top of page

End point title

Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16

End point description

The Adolescent Worst Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.

End point type

Secondary

End point timeframe

At Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	96 ^[54]	95 ^[55]	91 ^[56]
Units: Number of subjects with response	28	29	8

Notes
[54] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.
[55] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.
[56] - Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3.

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

187

Analysis specification

Pre-specified

Analysis type

superiority ^[57]

P-value

< 0.001 ^[58]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

20.3

Confidence interval

level

95%

sides

2-sided

lower limit

9.7

upper limit

Notes
[57] - The statistical test was not controlled for multiplicity.
[58] - Based on the primary analysis of the primary estimand 'composite'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

186

Analysis specification

Pre-specified

Analysis type

superiority ^[59]

P-value

< 0.001 ^[60]

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

21.8

Confidence interval

level

95%

sides

2-sided

lower limit

10.9

upper limit

32.7

Notes
[59] - The statistical test was not controlled for multiplicity.
[60] - Based on the primary analysis of the primary estimand 'composite'.

Secondary: Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16

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End point title

Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16

End point description

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on 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 (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.

End point type

Secondary

End point timeframe

From Week 0 to Week 16

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W	Initial treatment period - Placebo Q2W
Number of subjects analysed	94 ^[61]	95 ^[62]	87 ^[63]
Units: Adjusted mean change
least squares mean (standard error)	-8.4 ± 0.8	-7.8 ± 0.8	-2.4 ± 1.0

Notes
[61] - Subjects in the full analysis set with non-missing baseline POEM score.
[62] - Subjects in the full analysis set with non-missing baseline POEM score.
[63] - Subjects in the full analysis set with non-missing baseline POEM score.

Tralokinumab 300 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 300 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority ^[64]

P-value

< 0.001 ^[65]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-8.4

upper limit

-3.6

Notes
[64] - The statistical test was not controlled for multiplicity.
[65] - ents Based on the primary analysis of the primary estimand 'hypothetical'.

Tralokinumab 150 mg Q2W versus Placebo

Statistical analysis description

Comparison groups

Initial treatment period - Tralokinumab 150 mg Q2W v Initial treatment period - Placebo Q2W

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority ^[66]

P-value

< 0.001 ^[67]

Method

Repeated measurements model

Parameter type

Difference of least square means

Point estimate

-5.4

Confidence interval

level

95%

sides

2-sided

lower limit

-7.9

upper limit

-3

Notes
[66] - The statistical test was not controlled for multiplicity.
[67] - Based on the primary analysis of the primary estimand 'hypothetical'.

Secondary: Tralokinumab Serum Trough Concentration at Week 16

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End point title

Tralokinumab Serum Trough Concentration at Week 16 ^[68]

End point description

Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.

End point type

Secondary

End point timeframe

At Week 16

Notes
[68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Tralokinumab serum trough concentration was not analysed for subjects who were not randomised to tralokinumab.

End point values	Initial treatment period - Tralokinumab 300 mg Q2W	Initial treatment period - Tralokinumab 150 mg Q2W
Number of subjects analysed	89	87
Units: microgram/mL
geometric mean (geometric coefficient of variation)	105.7 ± 39.0	56.4 ± 35.4

No statistical analyses for this end point

Secondary: Subjects With Investigator’s Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

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End point title

Subjects With Investigator’s Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

End point description

The 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).

End point type

Secondary

End point timeframe

At Week 52

End point values	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Maintenance Treatment Period - Tralokinumab 150 mg Q2W	Maintenance Treatment Period - Tralokinumab 150 mg Q4W
Number of subjects analysed	11	13	12	14
Units: Number of subjects with response	4	7	6	7

No statistical analyses for this end point

Secondary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

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End point title

Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

End point description

End point type

Secondary

End point timeframe

At Week 52

End point values	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Maintenance Treatment Period - Tralokinumab 150 mg Q2W	Maintenance Treatment Period - Tralokinumab 150 mg Q4W
Number of subjects analysed	11	13	12	14
Units: Number of subjects with response	5	7	7	7

No statistical analyses for this end point

Secondary: Tralokinumab Serum Trough Concentration at Week 66

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End point title

Tralokinumab Serum Trough Concentration at Week 66

End point description

Serum samples for determination of tralokinumab concentrations were analysed by a laboratory using a validated bioanalytical method.

End point type

Secondary

End point timeframe

At Week 66

End point values	Open-label Treatment - Tralokinumab 300 mg Q2W + optional TCS	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Maintenance Treatment Period - Tralokinumab 150 mg Q2W	Maintenance Treatment Period - Tralokinumab 150 mg Q4W
Number of subjects analysed	234	1	5	4	3
Units: microgram/mL
geometric mean (geometric coefficient of variation)	4.4 ± 136.5	5.9 ± 0	1.0 ± 458.0	1.5 ± 168.6	2.6 ± 75.6

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Timeframe for AE

Adverse event reporting additional description

AE additional description

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Initial Treatment Period - Tralokinumab 300 Q2W

Reporting group description

Reporting group title

Initial Treatment Period - Tralokinumab 150 Q2W

Reporting group description

Reporting group title

Initial Treatment Period - Placebo

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 300 Q2W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 300 Q4W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 150 Q2W

Reporting group description

Reporting group title

Maintenance Treatment Period - Tralokinumab 150 Q4W

Reporting group description

Reporting group title

Maintenance Treatment Period - Placebo

Reporting group description

Reporting group title

Open-label Treatment - Tralokinumab 300 Q2W + optional TCS

Reporting group description

Reporting group title

Safety Follow-up

Reporting group description

Serious adverse events	Initial Treatment Period - Tralokinumab 300 Q2W	Initial Treatment Period - Tralokinumab 150 Q2W	Initial Treatment Period - Placebo	Maintenance Treatment Period - Tralokinumab 300 Q2W	Maintenance Treatment Period - Tralokinumab 300 Q4W	Maintenance Treatment Period - Tralokinumab 150 Q2W	Maintenance Treatment Period - Tralokinumab 150 Q4W	Maintenance Treatment Period - Placebo	Open-label Treatment - Tralokinumab 300 Q2W + optional TCS	Safety Follow-up
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 97 (1.03%)	3 / 98 (3.06%)	5 / 94 (5.32%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	7 / 234 (2.99%)	3 / 234 (1.28%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intentional overdose
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	1 / 234 (0.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	1 / 97 (1.03%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	1 / 234 (0.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastritis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Anorexia nervosa
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obsessive-compulsive disorder
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Renal injury
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	1 / 234 (0.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis perforated
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Initial Treatment Period - Tralokinumab 300 Q2W	Initial Treatment Period - Tralokinumab 150 Q2W	Initial Treatment Period - Placebo	Maintenance Treatment Period - Tralokinumab 300 Q2W	Maintenance Treatment Period - Tralokinumab 300 Q4W	Maintenance Treatment Period - Tralokinumab 150 Q2W	Maintenance Treatment Period - Tralokinumab 150 Q4W	Maintenance Treatment Period - Placebo	Open-label Treatment - Tralokinumab 300 Q2W + optional TCS	Safety Follow-up
Total subjects affected by non serious adverse events
subjects affected / exposed	44 / 97 (45.36%)	47 / 98 (47.96%)	36 / 94 (38.30%)	7 / 11 (63.64%)	6 / 13 (46.15%)	7 / 12 (58.33%)	8 / 14 (57.14%)	4 / 6 (66.67%)	100 / 234 (42.74%)	16 / 234 (6.84%)
Injury, poisoning and procedural complications
Inappropriate schedule of drug administration
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	2 / 234 (0.85%)	0 / 234 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	2	0
Procedural anxiety
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0
Wrong drug administered
subjects affected / exposed	1 / 97 (1.03%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0
Nervous system disorders
Headache
subjects affected / exposed	6 / 97 (6.19%)	5 / 98 (5.10%)	3 / 94 (3.19%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	12 / 234 (5.13%)	0 / 234 (0.00%)
occurrences all number	6	5	3	0	0	0	0	0	17	0
Migraine
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	2 / 234 (0.85%)	0 / 234 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	2	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 97 (0.00%)	4 / 98 (4.08%)	4 / 94 (4.26%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	4	4	1	0	0	0	0	0	0
Injection site reaction
subjects affected / exposed	2 / 97 (2.06%)	6 / 98 (6.12%)	0 / 94 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	10 / 234 (4.27%)	0 / 234 (0.00%)
occurrences all number	3	9	0	0	1	0	0	0	16	0
Malaise
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 6 (0.00%)	2 / 234 (0.85%)	0 / 234 (0.00%)
occurrences all number	0	2	0	0	0	6	0	0	12	0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0
Eye disorders
Cataract
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Conjunctivitis allergic
subjects affected / exposed	2 / 97 (2.06%)	2 / 98 (2.04%)	2 / 94 (2.13%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	1 / 14 (7.14%)	0 / 6 (0.00%)	4 / 234 (1.71%)	0 / 234 (0.00%)
occurrences all number	2	2	3	0	0	1	1	0	4	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	4 / 97 (4.12%)	1 / 98 (1.02%)	3 / 94 (3.19%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	4 / 234 (1.71%)	0 / 234 (0.00%)
occurrences all number	4	2	3	0	1	0	1	0	4	0
Rhinorrhoea
subjects affected / exposed	1 / 97 (1.03%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	2 / 234 (0.85%)	0 / 234 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	2	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	3 / 97 (3.09%)	0 / 98 (0.00%)	4 / 94 (4.26%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	1 / 14 (7.14%)	0 / 6 (0.00%)	3 / 234 (1.28%)	1 / 234 (0.43%)
occurrences all number	3	0	4	0	0	1	1	0	3	1
Dermatitis allergic
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Dermatitis atopic
subjects affected / exposed	7 / 97 (7.22%)	12 / 98 (12.24%)	11 / 94 (11.70%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	2 / 14 (14.29%)	1 / 6 (16.67%)	19 / 234 (8.12%)	8 / 234 (3.42%)
occurrences all number	7	16	15	0	0	1	2	1	26	9
Dermatitis contact
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	1	0
Psychiatric disorders
Abnormal behaviour
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Attention deficit/hyperactivity disorder
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Bursitis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 6 (0.00%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0
Infections and infestations
Acute sinusitis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	1	0	0	2	0	0	0	0
Bacterial vaginosis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 97 (0.00%)	2 / 98 (2.04%)	0 / 94 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	4 / 234 (1.71%)	2 / 234 (0.85%)
occurrences all number	0	2	0	0	1	0	0	0	6	2
Furuncle
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Herpes zoster
subjects affected / exposed	0 / 97 (0.00%)	1 / 98 (1.02%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 6 (16.67%)	1 / 234 (0.43%)	0 / 234 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	1	0
Infectious mononucleosis
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	0 / 94 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 6 (0.00%)	0 / 234 (0.00%)	0 / 234 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Influenza
subjects affected / exposed	2 / 97 (2.06%)	2 / 98 (2.04%)	1 / 94 (1.06%)	2 / 11 (18.18%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	3 / 234 (1.28%)	2 / 234 (0.85%)
occurrences all number	2	2	1	2	0	0	0	0	3	2
Oral herpes
subjects affected / exposed	0 / 97 (0.00%)	0 / 98 (0.00%)	1 / 94 (1.06%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	6 / 234 (2.56%)	0 / 234 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	7	0
Pharyngitis
subjects affected / exposed	0 / 97 (0.00%)	2 / 98 (2.04%)	4 / 94 (4.26%)	0 / 11 (0.00%)	0 / 13 (0.00%)	3 / 12 (25.00%)	0 / 14 (0.00%)	0 / 6 (0.00%)	6 / 234 (2.56%)	1 / 234 (0.43%)
occurrences all number	0	2	4	0	0	4	0	0	6	1
Upper respiratory tract infection
subjects affected / exposed	11 / 97 (11.34%)	8 / 98 (8.16%)	4 / 94 (4.26%)	2 / 11 (18.18%)	0 / 13 (0.00%)	1 / 12 (8.33%)	1 / 14 (7.14%)	0 / 6 (0.00%)	25 / 234 (10.68%)	3 / 234 (1.28%)
occurrences all number	11	10	5	2	0	2	1	0	34	3
Viral upper respiratory tract infection
subjects affected / exposed	12 / 97 (12.37%)	19 / 98 (19.39%)	8 / 94 (8.51%)	2 / 11 (18.18%)	1 / 13 (7.69%)	1 / 12 (8.33%)	1 / 14 (7.14%)	0 / 6 (0.00%)	44 / 234 (18.80%)	1 / 234 (0.43%)
occurrences all number	16	22	10	2	1	2	1	0	60	2

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Were there any global substantial amendments to the protocol? Yes

12 Jun 2018

The main reason for this amendment was extension of the post-IMP observation period at the first 3 visits in the initial treatment period and in the in open label treatment period from 30 minutes to 2 hours.

06 Feb 2020

The main reason for this amendment was introduction of the possibility for eligible subjects in selected countries to continue in a long-term extension trial (ECZTEND). Subjects could enter ECZTEND from completion of the treatment period and up to 26 weeks from their last IMP injection in the present trial to the first IMP injection in ECZTEND.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

Primary: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

Primary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

Primary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16

Secondary: Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16

Secondary: Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16

Secondary: Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

Secondary: Change in Children’s Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16

Secondary: Number of Adverse Events

Secondary: Number of Adverse Events

Secondary: Presence of Anti-drug Antibodies

Secondary: Presence of Anti-drug Antibodies

Secondary: Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.

Secondary: Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.

Secondary: Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.

Secondary: Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.

Secondary: Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16

Secondary: Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16

Secondary: Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16

Secondary: Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16

Secondary: Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16

Secondary: Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16

Secondary: Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16

Secondary: Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16

Secondary: Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16

Secondary: Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16

Secondary: Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16

Secondary: Tralokinumab Serum Trough Concentration at Week 16

Secondary: Tralokinumab Serum Trough Concentration at Week 16

Secondary: Subjects With Investigator’s Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

Secondary: Subjects With Investigator’s Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

Secondary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

Secondary: Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16

Secondary: Tralokinumab Serum Trough Concentration at Week 66

Secondary: Tralokinumab Serum Trough Concentration at Week 66

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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