Tralokinumab in Combination With Topical Corticosteroids... | NCT03363854

ID	Type	Description	Link
2017-002065-21	EudraCT Number

Tralokinumab in Combination With Topical Corticosteroids... | NCT03363854 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tralokinumab(initial)responders-> Tralokinumab(continuation A)	Experimental	Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.	Drug: Tralokinumab
Tralokinumab(initial)responders-> Tralokinumab(continuation B)	Experimental	Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen B.	Drug: Tralokinumab
Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)	Experimental	Week 0 to 16 (initial period): Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.	Drug: Tralokinumab
Placebo (initial)non-respon-> Tralokinumab(continuation A)	Experimental	Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 32 (continuation period): Tralokinumab continuation SC injection regimen A.	Drug: Tralokinumab Drug: Placebo
Placebo(initial)responders-> Placebo(continuation A)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tralokinumab	Drug	Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).	Week 16
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16	EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.	Week 16

Secondary Outcomes

Measure	Description	Time Frame
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16	Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.	Week 0 to Week 16

Contacts/Locations Module

Name	Affiliation	Role
Medical expert	LEO Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama-Birmingham		Birmingham	Alabama	35233	United States
California Dermatology & Clinical Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41118053	Derived	Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2026 Jan;27(1):149-166. doi: 10.1007/s40257-025-00985-1. Epub 2025 Oct 21.
41102518

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 29, 2018	Sep 8, 2020

Continuation Treatment Period

Type	Comment	Milestone Data
STARTED	Between the inital and continuation treatment periods, 2 participants discontinued treatment.	FG0000 subjectsThis treatment group applies to the initial treatment period (see above). FG0010 subjectsThis treatment group applies to the initial treatment period (see above). FG00269 subjects FG00369 subjects FG00495 subjects FG00579 subjects FG00641 subjects FG0070 subjectsThis treatment group applies to the safety follow-up period (see below).
COMPLETED		FG0000 subjects FG0010 subjects FG00268 subjects FG00365 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0021 subjects FG0034 subjects FG004

Safety Follow-up Period

Type	Comment	Milestone Data
STARTED		FG0000 subjectsThis treatment group applies to the initial treatment period (see above). FG0010 subjectsThis treatment group applies to the initial treatment period (see above). FG0020 subjectsThis treatment group applies to the continuation treatment period (see above). FG0030 subjectsThis treatment group applies to the continuation treatment period (see above). FG0040 subjectsThis treatment group applies to the continuation treatment period (see above). FG0050 subjectsThis treatment group applies to the continuation treatment period (see above). FG0060 subjectsThis treatment group applies to the continuation treatment period (see above). FG007278 subjects
COMPLETED	Of the 278 participants who started safety follow-up, 180 transferred to the extension trial.	FG0000 subjects FG0010 subjects FG0020 subjects FG003
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
BG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

In this trial, there were 2 age groups: 18-64 years (corresponding to 'between 18 and 65 years') and 65-84 years (corresponding to '>=65 years').

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG000253
- ParticipantsBG001127
- ParticipantsBG002380

Title	Measurements
<=18 years

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
Race	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
Belgium	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Age at onset of atopic dermatitis

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

Median

Inter-Quartile Range

years

Title	Denominators	Categories
	ParticipantsBG000253 ParticipantsBG001126 ParticipantsBG002

Duration of atopic dermatitis

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

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000253 ParticipantsBG001126 ParticipantsBG002

Body surface area with atopic dermatitis

Mean

Standard Deviation

percentage affected

Title	Denominators	Categories
	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Investigator's Global Assessment (IGA)

IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

Count of Participants

Participants

Title	Denominators	Categories
Clear	ParticipantsBG000253 ParticipantsBG001127 ParticipantsBG002

Eczema Area and Severity Index (EASI)

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

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

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000252 ParticipantsBG001126 Participants

Worst Daily Pruritus numeric rating scale (NRS) (weekly average)

Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable').

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

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000251 ParticipantsBG001126 Participants

Scoring Atopic Dermatitis (SCORAD)

SCORAD is used to evaluate the extent and severity of atopic dermatitis as well as subjective symptoms. The score ranges from 0 to 103 with a higher score indicating a more extensive and/or severe condition.

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

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000252 ParticipantsBG001126 Participants

Dermatology Life Quality Index (DLQI)

DLQI is used by the participant to evaluate the impact of their condition on 10 different aspects of health-related quality of life (HRQoL) over the last week. Each item is scored on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much). The total score which is the sum of the 10 items ranges from 0 to 30, with a higher score indicating a poorer HRQoL.

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

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG000250 ParticipantsBG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants	OG000252 OG001126

Title

Denominators

Categories

Title	Measurements
	OG00098 OG00133

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	0.015	The primary endpoints were tested sequentially at a 5% significance level.	Risk Difference (RD)	12.4			2-Sided	95	2.9	21.9

Primary

Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

Full analysis set (FAS). Of the 380 participants randomised to initial treatment, 378 were treated. Therefore, the FAS consisted of 378 participants (252 + 126).

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

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

Worst Daily Pruritus NRS is used by the participant to evaluate their worst itch severity over the past 24 hours. The score ranges from 0 ('no itch') to 10 ('worst itch imaginable') on an 11-point scale.

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

Posted

Count of Participants

Participants

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

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

Full analysis set

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16

Full analysis set

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Secondary

Frequency of Anti-drug Antibodies (ADA)

Presence of ADA from Week 0 to Week 32 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment. Perishing ADAs were not assessed in the continuation treatment period.

Safety analysis set (378 participants). Data was collected for the treatment groups applicable in each treatment period, i.e. tralokinumab Q2W+TCS and placebo+TCS treatment groups in the initial treatment period and the 5 continuation treatment groups (see table below) in the continuation treatment period.

Posted

Count of Participants

Participants

Week 0 to Week 16, Week 16 to Week 32

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Initial Treatment Period - Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Secondary

Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes

Assessed as the amount of TCS weighed from previous visits, assuming no TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.

Posted

Least Squares Mean

Standard Error

Week 1-2 to Week 15-16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes

Assessed as the amount of TCS weighed from previous visits, assuming all TCS was used from the non-returned tubes. Measurements were collected as TCS weight (g) between the visits.

Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.

Posted

Least Squares Mean

Standard Error

Week 1-2 to Week 15-16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

Number of Atopic Dermatitis Flares Through Week 16

Assessed as appearance of new flares since previous visit.

Full analysis set. All observed data

Posted

Number

number of flares

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants	OG000

Secondary

Number of Days Without Topical Treatment Use From Baseline to Week 16

Participants assessed their use of topical treatment over the past 24 hours using a response scale ('yes', 'no'). Measurements of number of days per week were used in the analysis.

Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.

Posted

Least Squares Mean

Standard Error

days

Week 1 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

Full analysis set

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

Full analysis set

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

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

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

Full analysis set

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16

Full analysis set

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

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

Full analysis set. Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units

Secondary

Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4

Participants in the full analysis set with DLQI of at least 4 at baseline (Week 0).

Posted

Count of Participants

Participants

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Secondary

Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab

IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).

Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved IGA score of 0 or 1 at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.

Posted

Count of Participants

Participants

Week 32

ID	Title	Description
OG000	Tralokinumab R/Q2W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
OG001	Tralokinumab R/Q4W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as IGA score of 0 or 1 at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.

Secondary

Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab

EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.

Participants in the continuation treatment analysis set treated with tralokinumab Q2W+TCS in the initial treatment period and who achieved at least 75% reduction in EASI at Week 16 without rescue medication. Participants who received rescue medication prior to Week 32 or with missing data at Week 32 were not included in the analysis.

Posted

Count of Participants

Participants

Week 32

ID	Title	Description
OG000	Tralokinumab R/Q2W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as a reduction in EASI of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.
OG001	Tralokinumab R/Q4W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as a reduction in EASI of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Treatment Period: Tralokinumab Q2W+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.	252	2	252	118	252
EG001	Initial Treatment Period: Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.	126	4	126	36	126
EG002	Continuation Treatment Period: Tralokinumab R/Q2W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.	69	3	69	30	69
EG003	Continuation Treatment Period: Tralokinumab R/Q4W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and re-randomised to tralokinumab every fourth week (Q4W) and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received alternating doses of 300 mg tralokinumab and placebo Q2W from Week 16 to Week 30.	69	0	69	24	69
EG004	Continuation Treatment Period: Tralokinumab NR/Q2W+TCS	Participants treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.	95	2	95	41	95
EG005	Continuation Treatment Period: Placebo NR/Tralokinumab Q2W+TCS	Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), without a clinical response at Week 16 (NR: non-responder) i.e. not having Investigator's Global Assessment score of 0 or 1 at Week 16 nor a reduction in Eczema Area and Severity Index of at least 75% at Week 16, and assigned tralokinumab Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants received a dose of 300 mg tralokinumab Q2W from Week 16 to Week 30.	79	0	79	32	79
EG006	Continuation Treatment Period: Placebo R/Placebo+TCS	Participants treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed in the initial treatment period (Week 0 to Week 16), with a clinical response at Week 16 (R: responder) defined as Investigator's Global Assessment score of 0 or 1 at Week 16 or a reduction in Eczema Area and Severity Index of at least 75% at Week 16 achieved without rescue treatment, and assigned placebo Q2W and TCS as needed in the continuation treatment period (Week 16 to Week 32). Participants were administered placebo Q2W from Week 16 to Week 30.	41	1	41	12	41
EG007	Safety Follow-up	Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. In selected countries, eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.	278	3	278	10	278

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroduodenitis	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG0030 events0 affected69 at risk EG0040 events0 affected95 at risk EG0050 events0 affected79 at risk EG0060 events0 affected41 at risk EG0070 events0 affected278 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Appendicitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0021 events1 affected69 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected126 at risk EG0020 events0 affected69 at risk EG003
Gastroenteritis clostridial	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0021 events1 affected69 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected126 at risk EG0020 events0 affected69 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected126 at risk EG0020 events0 affected69 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0021 events1 affected69 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0021 events1 affected69 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected126 at risk EG0020 events0 affected69 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected126 at risk EG0020 events0 affected69 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0008 events8 affected252 at risk EG0012 events2 affected126 at risk EG0024 events4 affected69 at risk EG0031 events1 affected69 at risk EG0042 events1 affected95 at risk EG0052 events2 affected79 at risk EG0062 events2 affected41 at risk EG0071 events1 affected278 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected126 at risk EG0023 events3 affected69 at risk EG003
Injection site reaction	General disorders	MedDRA 20.0	Non-systematic Assessment	EG00030 events17 affected252 at risk EG0010 events0 affected126 at risk EG00214 events5 affected69 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00032 events28 affected252 at risk EG0014 events4 affected126 at risk EG0024 events4 affected69 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0006 events4 affected252 at risk EG0012 events1 affected126 at risk EG0023 events3 affected69 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00021 events19 affected252 at risk EG0017 events6 affected126 at risk EG0028 events7 affected69 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00064 events49 affected252 at risk EG00118 events14 affected126 at risk EG00213 events12 affected69 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG00026 events22 affected252 at risk EG0019 events6 affected126 at risk EG0022 events2 affected69 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0008 events6 affected252 at risk EG00112 events10 affected126 at risk EG0021 events1 affected69 at risk EG003

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Title	Measurements
White	BG000203 BG00185 BG002288
Black or African American	BG00023 BG00112 BG00235
Asian	BG00017 BG00124 BG00241
Native Hawaiian or Other Pacific Islander	BG0001 BG0011 BG0022
Other	BG0009 BG0015 BG00214
Hispanic or Latino	BG0000 BG0010 BG0020
Not Hispanic or Latino	BG0000 BG0010 BG0020

Ethnicity

- ParticipantsBG000253
- ParticipantsBG001127
- ParticipantsBG002380

Title	Measurements
White	BG0000 BG0010 BG0020
Black or African American	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Other	BG0000 BG0010 BG0020
Hispanic or Latino	BG00025 BG0019 BG00234
Not Hispanic or Latino	BG000228 BG001118 BG002346

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	<0.001	The primary endpoints were tested sequentially at a 5% significance level.	Risk Difference (RD)	20.2			2-Sided	95	9.8	30.6					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	0.037	This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.	Risk Difference (RD)	11.3			2-Sided	95	0.9	21.6					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.	Repeated measurements model		<0.001	This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.	Difference	-10.9			2-Sided	95	-15.2	-6.6					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.	Repeated measurements model		<0.001	This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.	Difference	-2.9			2-Sided	95	-4.3	-1.6					Superiority

Title

Denominators

Categories

Initial treatment period (Week 0 to Week 16)

- ParticipantsOG000252
- ParticipantsOG001126
- ParticipantsOG0020
- ParticipantsOG0030
- ParticipantsOG0040
- ParticipantsOG0050
- ParticipantsOG0060

Title	Measurements
Positive	OG0002 OG0013 OG0020 OG003

Continuation treatment period (Week 16 to Week 32)

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG00266
- ParticipantsOG003

Title

Denominators

Categories

Week 1-2

- ParticipantsOG000250
- ParticipantsOG001125

Title	Measurements
	OG00029.3± 2.45 OG00132.8± 3.47

Week 3-4

- ParticipantsOG000248
- ParticipantsOG001121

Title	Measurements
	OG00019.7± 1.86 OG001

Week 5-6

- ParticipantsOG000245
- ParticipantsOG001118

Title	Measurements
	OG00018.5± 1.72 OG001

Week 7-8

- ParticipantsOG000240
- ParticipantsOG001114

Title	Measurements
	OG00017.0± 2.04 OG001

Week 9-10

- ParticipantsOG000236
- ParticipantsOG001113

Title	Measurements
	OG00014.8± 1.66 OG001

Week 11-12

- ParticipantsOG000234
- ParticipantsOG001110

Title	Measurements
	OG00011.6± 1.38 OG001

Week 13-14

- ParticipantsOG000232
- ParticipantsOG001108

Title	Measurements
	OG00012.7± 1.61 OG001

Week 15-16

- ParticipantsOG000229
- ParticipantsOG001108

Title	Measurements
	OG00011.6± 1.57 OG001

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.	Repeated measurements model	0.41	The statistical test was not controlled for multiplicity.	Difference	-3.5	2-Sided	95	-11.9	4.9	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.	Repeated measurements model	0.033	The statistical test was not controlled for multiplicity.	Difference	-6.9	2-Sided	95	-13.3	-0.6	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.	Repeated measurements model	0.12	The statistical test was not controlled for multiplicity.	Difference	-4.7	2-Sided	95	-10.6	1.2	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.	Repeated measurements model	0.043	The statistical test was not controlled for multiplicity.	Difference	-7.3	2-Sided	95	-14.3	-0.2	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.	Repeated measurements model	0.002	The statistical test was not controlled for multiplicity.	Difference	-9.1	2-Sided	95	-14.8	-3.4	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.	Repeated measurements model	0.001	The statistical test was not controlled for multiplicity.	Difference	-8.0	2-Sided	95	-12.8	-3.2	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.	Repeated measurements model	<0.001	The statistical test was not controlled for multiplicity.	Difference	-10.2	2-Sided	95	-15.8	-4.7	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.	Repeated measurements model	0.002	The statistical test was not controlled for multiplicity.	Difference	-8.6	2-Sided	95	-14.1	-3.2	Superiority

Title

Denominators

Categories

Week 1-2

- ParticipantsOG000250
- ParticipantsOG001125

Title	Measurements
	OG00040.1± 3.22 OG00140.1± 4.57

Week 3-4

- ParticipantsOG000248
- ParticipantsOG001121

Title	Measurements
	OG00032.4± 3.00 OG001

Week 5-6

- ParticipantsOG000245
- ParticipantsOG001118

Title	Measurements
	OG00029.2± 2.89 OG001

Week 7-8

- ParticipantsOG000240
- ParticipantsOG001114

Title	Measurements
	OG00025.2± 2.89 OG001

Week 9-10

- ParticipantsOG000236
- ParticipantsOG001113

Title	Measurements
	OG00022.5± 2.61 OG001

Week 11-12

- ParticipantsOG000234
- ParticipantsOG001110

Title	Measurements
	OG00016.9± 2.23 OG001

Week 13-14

- ParticipantsOG000232
- ParticipantsOG001108

Title	Measurements
	OG00016.6± 2.22 OG001

Week 15-16

- ParticipantsOG000229
- ParticipantsOG001108

Title	Measurements
	OG00015.3± 2.26 OG001

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.	Repeated measurements model	1.00	The statistical test was not controlled for multiplicity.	Difference	0.0	2-Sided	95	-11.0	11.0	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.	Repeated measurements model	0.83	The statistical test was not controlled for multiplicity.	Difference	1.1	2-Sided	95	-9.1	11.4	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.	Repeated measurements model	0.78	The statistical test was not controlled for multiplicity.	Difference	-1.4	2-Sided	95	-11.3	8.5	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.	Repeated measurements model	0.34	The statistical test was not controlled for multiplicity.	Difference	-4.8	2-Sided	95	-14.8	5.1	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.	Repeated measurements model	0.34	The statistical test was not controlled for multiplicity.	Difference	-4.4	2-Sided	95	-13.4	4.6	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.	Repeated measurements model	0.11	The statistical test was not controlled for multiplicity.	Difference	-6.2	2-Sided	95	-13.9	1.5	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.	Repeated measurements model	0.024	The statistical test was not controlled for multiplicity.	Difference	-8.9	2-Sided	95	-16.6	-1.2	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.	Repeated measurements model	0.017	The statistical test was not controlled for multiplicity.	Difference	-9.5	2-Sided	95	-17.3	-1.7	Superiority

Title

Denominators

Categories

Week 1

- ParticipantsOG000210
- ParticipantsOG00199

Title	Measurements
	OG0002.6± 0.17 OG0012.5± 0.25

Week 2

- ParticipantsOG000208
- ParticipantsOG00198

Title	Measurements
	OG0003.0± 0.18 OG001

Week 3

- ParticipantsOG000219
- ParticipantsOG001104

Title	Measurements
	OG0002.9± 0.17 OG001

Week 4

- ParticipantsOG000220
- ParticipantsOG00198

Title	Measurements
	OG0003.1± 0.17 OG001

Week 5

- ParticipantsOG000217
- ParticipantsOG00197

Title	Measurements
	OG0003.2± 0.17 OG001

Week 6

- ParticipantsOG000216
- ParticipantsOG001102

Title	Measurements
	OG0003.1± 0.18 OG001

Week 7

- ParticipantsOG000209
- ParticipantsOG00196

Title	Measurements
	OG0003.3± 0.17 OG001

Week 8

- ParticipantsOG000208
- ParticipantsOG00197

Title	Measurements
	OG0003.3± 0.18 OG001

Week 9

- ParticipantsOG000217
- ParticipantsOG00198

Title	Measurements
	OG0003.6± 0.17 OG001

Week 10

- ParticipantsOG000217
- ParticipantsOG00196

Title	Measurements
	OG0003.4± 0.17 OG001

Week 11

- ParticipantsOG000213
- ParticipantsOG00197

Title	Measurements
	OG0003.6± 0.18 OG001

Week 12

- ParticipantsOG000218
- ParticipantsOG00197

Title	Measurements
	OG0003.4± 0.18 OG001

Week 13

- ParticipantsOG000216
- ParticipantsOG00195

Title	Measurements
	OG0003.5± 0.18 OG001

Week 14

- ParticipantsOG000206
- ParticipantsOG00198

Title	Measurements
	OG0003.3± 0.18 OG001

Week 15

- ParticipantsOG000207
- ParticipantsOG00197

Title	Measurements
	OG0003.5± 0.18 OG001

Week 16

- ParticipantsOG000210
- ParticipantsOG00196

Title	Measurements
	OG0003.4± 0.19 OG001

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.	Repeated measurements model	0.64	The statistical test was not controlled for multiplicity.	Difference	0.1	2-Sided	95	-0.5	0.7	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.	Repeated measurements model	0.26	The statistical test was not controlled for multiplicity.	Difference	0.4	2-Sided	95	-0.3	1.0	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.	Repeated measurements model	0.46	The statistical test was not controlled for multiplicity.	Difference	0.2	2-Sided	95	-0.4	0.8	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.	Repeated measurements model	0.16	The statistical test was not controlled for multiplicity.	Difference	0.4	2-Sided	95	-0.2	1.0	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.	Repeated measurements model	0.13	The statistical test was not controlled for multiplicity.	Difference	0.5	2-Sided	95	-0.1	1.1	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.	Repeated measurements model	0.38	The statistical test was not controlled for multiplicity.	Difference	0.3	2-Sided	95	-0.3	0.9	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.	Repeated measurements model	0.040	The statistical test was not controlled for multiplicity.	Difference	0.6	2-Sided	95	0.0	1.2	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.	Repeated measurements model	0.31	The statistical test was not controlled for multiplicity.	Difference	0.3	2-Sided	95	-0.3	1.0	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.	Repeated measurements model	0.001	The statistical test was not controlled for multiplicity.	Difference	1.0	2-Sided	95	0.4	1.6	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.	Repeated measurements model	0.026	The statistical test was not controlled for multiplicity.	Difference	0.7	2-Sided	95	0.1	1.3	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.	Repeated measurements model]	0.006	The statistical test was not controlled for multiplicity.	Difference	0.9	2-Sided	95	0.2	1.5	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.	Repeated measurements model	0.043	The statistical test was not controlled for multiplicity.	Difference	0.6	2-Sided	95	0.0	1.3	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.	Repeated measurements model	0.010	The statistical test was not controlled for multiplicity.	Difference	0.8	2-Sided	95	0.2	1.4	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.	Repeated measurements model	0.037	The statistical test was not controlled for multiplicity.	Difference	0.7	2-Sided	95	0.0	1.3	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.	Repeated measurements model	0.045	The statistical test was not controlled for multiplicity.	Difference	0.6	2-Sided	95	0.0	1.3	Superiority
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.	Repeated measurements model	0.17	The statistical test was not controlled for multiplicity.	Difference	0.5	2-Sided	95	-0.2	1.1	Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	<0.001	The statistical test was not controlled for multiplicity.	Risk Difference (RD)	21.3			2-Sided	95	11.3	31.3					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	0.022	The statistical test was not controlled for multiplicity.	Risk Difference (RD)	11.4			2-Sided	95	2.1	20.7					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.	Repeated measurement model		<0.001	The statistical test was not controlled for multiplicity.	Difference	-5.4			2-Sided	95	-7.7	-3.1					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	<0.001	The statistical test was not controlled for multiplicity.	Risk Difference (RD)	22.9			2-Sided	95	12.4	33.3					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	0.012	The statistical test was not controlled for multiplicity.	Risk Difference (RD)	11.1			2-Sided	95	3.2	19.0					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.	Repeated measurements model		<0.001	The statistical test was not controlled for multiplicity.	Difference	-1.2			2-Sided	95	-1.7	-0.7					Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.	Cochran-Mantel-Haenszel	The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.	<0.001	The statistical test was not controlled for multiplicity.	Risk Difference (RD)	17.6			2-Sided	95	8.0	27.1					Superiority

Title	Measurements
Positive	OG0000 OG0010 OG0020 OG0032 OG0040 OG0053 OG0062
Perishing	OG0000 OG0010 OG0020 OG0030 OG004
Negative	OG0000 OG0010 OG00266 OG00363 OG004
No post-baseline ADA assessment	OG0000 OG0010 OG0020 OG0030 OG004