Tralokinumab Monotherapy for Adolescent Subjects With Mod... | NCT03526861

ID	Type	Description	Link
2017-005143-33	EudraCT Number

Tralokinumab Monotherapy for Adolescent Subjects With Mod... | NCT03526861 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA	Experimental	Week 0 to 16 (initial period): Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 1) maintenance SC injection regimen A.	Drug: Tralokinumab
Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB	Experimental	Week 0 to 16 (initial period): Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 1) maintenance SC injection regimen B.	Drug: Tralokinumab
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA	Experimental	Week 0 to 16 (initial period): Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 2) maintenance SC injection regimen A.	Drug: Tralokinumab
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB	Experimental	Week 0 to 16 (initial period): Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A. Week 16 to 52 (maintenance period): Tralokinumab (Dose 2) maintenance SC injection regimen B.	Drug: Tralokinumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tralokinumab	Drug	Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	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).	At Week 16
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16	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.	At Week 16

Secondary Outcomes

Measure	Description	Time Frame
Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16	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'.	At Week 16

Contacts/Locations Module

Name	Affiliation	Role
Medical expert	LEO Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
LEO Pharma Investigational Site		Birmingham	Alabama	35209	United States
LEO Pharma Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37074705	Result	Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, Hong HC, Imafuku S, Schuttelaar MLA, Simpson EL, Soong W, Arlert P, Lophaven KW, Kurbasic A, Soldbro L, Vest NS, Wollenberg A. Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):596-605. doi: 10.1001/jamadermatol.2023.0627.
42033591

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 SC administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.

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	Feb 6, 2020	Sep 6, 2021

Type	Comment	Reasons
Not dosed		FG0001 subjects FG0011 subjects FG0021 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects FG0070 subjects FG0080 subjects
Randomised at site with quality/GCP issues identified, subject withdrawn from the trial		FG0003 subjects FG0011 subjects FG0025 subjects FG0030 subjects
Subject discontinued IMP before Week 16		FG0003 subjects FG0015 subjects FG0028 subjects FG0030 subjects FG004

Maintenance Treatment Period

Type	Comment	Milestone Data
STARTED	Maintenance treatment period was in parallel to the open-label treatment period.	FG0000 subjects FG0010 subjects FG0020 subjects FG00313 subjects FG00414 subjects FG00512 subjects FG00614 subjects FG0076 subjects FG0080 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0035 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0038 subjects FG004

Type	Comment	Reasons
Subject discontinued IMP between Week 16 and Week 52		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Open-label Treatment Period

Type	Comment	Milestone Data
STARTED	Open-label treatment period was in parallel to the maintenance treatment period.	FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0060 subjects FG0070 subjects FG008242 subjects226 subjects transferred to open-label treatment at Week 16. 24 subjects transferred to open-label treatment between Week 16 and Week 52.
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Subject discontinued IMP between Week 16 and Week 52		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
BG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.
BG002	Initial Treatment Period - Placebo	Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.
BG003	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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.6± 1.8 BG00114.8± 1.7 BG00214.4± 1.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00052 BG00148 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00110 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00059 BG00156 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00021 BG00119 BG002

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).

Count of Participants

Participants

Title

Denominators

Categories

Clear

Title	Measurements
	BG0000 BG001

Eczema Area and Severity Index

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00031.90± 13.74 BG001

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00068.41± 13.51 BG001

Children's Dermatology Life Quality Index

The Children's Dermatology Life Quality Index (DLQI) 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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00013.29± 7.18 BG001

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'.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.79± 1.53 BG001

Body surface area affected by atopic dermatitis (AD)

Mean

Standard Deviation

percentage affected

Title

Denominators

Categories

Title	Measurements
	BG00049.8± 23.0 BG00152.0± 22.5 BG002

Age of onset of atopic dermatitis (AD)

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0002.5± 3.5 BG0012.1± 3.3 BG002

Duration of atopic dermatitis (AD)

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00012.1± 3.7 BG00112.7± 3.7 BG002

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

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

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).

The full analysis set (FAS: All subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified) was used for the primary analysis.

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.
OG002	Initial Treatment Period - Placebo	Week 0 to Week 16: Placebo Q2W Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab. At Day 0, each subject received 4 subcutaneous injections (each 1.0 mL) of placebo. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of placebo.

Units	Counts
Participants	OG00097 OG00198 OG00294

Title

Denominators

Categories

Title	Measurements
	OG00017 OG00121 OG0024

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 OG002	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.	Cochran-Mantel-Haenszel		0.002	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	13.8			2-Sided	95	5.3	22.3			Mantel-Haenszel risk difference, stratified by region and baseline disease severity.

Primary

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

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.

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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'.

Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥4. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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.

Posted

Least Squares Mean

Standard Error

units on a scale

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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.

Subjects in the full analysis set with non-missing baseline CDLQI score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Posted

Least Squares Mean

Standard Error

units on a scale

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.

Secondary

Number of Adverse Events

Number of AEs during the Initial treatment period is presented. For a summary 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.

The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment and exposed to IMP, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified . The safety analysis set was identical to the full analysis set.

Posted

Number

number of adverse events

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W

Secondary

Presence of Anti-drug Antibodies

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

The analysis was performed on the safety analysis set. The safety analysis set comprised all subjects randomised to initial treatment, except for subjects randomised at the investigational sites where substantial quality/GCP issues were identified and subjects for whom no post-baseline safety data were available. The safety analysis set was identical to the full analysis set.

Posted

Count of Participants

Participants

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

Posted

Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

Posted

Least Squares Mean

Standard Error

units on a scale

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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.

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Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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'.

Subjects in the full analysis set with non-missing baseline Adolescent Worst Pruritus NRS score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Posted

Least Squares Mean

Standard Error

units on a scale

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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'.

Subjects in the full analysis set with baseline Adolescent Worst Pruritus weekly average ≥3. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

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Count of Participants

Participants

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

Secondary

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

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.

Subjects in the full analysis set with non-missing baseline POEM score. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Posted

Least Squares Mean

Standard Error

units on a scale

From Week 0 to Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.

Secondary

Tralokinumab Serum Trough Concentration at Week 16

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

Subjects in the full analysis set who were randomised to tralokinumab. The full analysis set (FAS) comprised all subjects randomised to initial treatment who were exposed to IMP and not randomised at the investigational sites where substantial quality/GCP issues were identified.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/mL

At Week 16

ID	Title	Description
OG000	Initial Treatment Period - Tralokinumab 300 mg Q2W	Week 0 to Week 16: Tralokinumab 300 mg Q2W Tralokinumab: 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 administration. 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. At subsequent visits (Q2W) each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Initial Treatment Period - Tralokinumab 150 mg Q2W	Week 0 to Week 16: Tralokinumab 150 mg Q2W. Tralokinumab: 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 administration. At Day 0, each subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab and 2 subcutaneous injections (each 1.0 mL) of placebo to receive a total loading dose of 300 mg tralokinumab. At subsequent visits (Q2W) each subject received 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 150 mg tralokinumab.

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

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).

Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 without use of rescue medication from Week 2 to Week 16.

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Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.

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

Subjects in the full analysis set (FAS) who were re-randomised to maintenance treatment and achieved at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 without use of rescue medication from Week 2 to Week 16.

Posted

Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.

Secondary

Tralokinumab Serum Trough Concentration at Week 66

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

13 subjects in maintenance safety analysis set who were initially randomised to tralokinumab and completed the maintenance treatment period on treatment. 234 subjects in the open-label safety analysis set.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/mL

At Week 66

ID	Title	Description
OG000	Maintenance Treatment Period - Tralokinumab 300 mg Q2W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen. At each visit (Q2W), subject received 2 subcutaneous injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
OG001	Maintenance Treatment Period - Tralokinumab 300 mg Q4W	Week 16 to Week 52: Subjects achieving a clinical response at Week 16 without use of rescue medication from Week 2 to Week 16 and initially randomised to tralokinumab 300 mg Q2W, re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen. At each visit (Q2W), subject received alternating dose administrations: 2 subcutaneous injection (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab; or 2 subcutaneous injections (each 1.0 mL) of placebo.

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 300 Q2W	Initial Treatment Period - Tralokinumab 300 Q2W (n=97, PYE=29.48)	97	1	97	44	97
EG001	Initial Treatment Period - Tralokinumab 150 Q2W	Initial Treatment Period - Tralokinumab 150 Q2W (n=98, PYE=29.33)	98	3	98	47	98
EG002	Initial Treatment Period - Placebo	Initial Treatment Period - Placebo (n=94, PYE=27.93)	94	5	94	36	94
EG003	Maintenance Treatment Period - Tralokinumab 300 Q2W	Maintenance Treatment Period - Tralokinumab 300 Q2W (n=11, PYE=5.61)	11	0	11	7	11
EG004	Maintenance Treatment Period - Tralokinumab 300 Q4W	Maintenance Treatment Period - Tralokinumab 300 Q4W (n=13, PYE=6.78)	13	0	13	6	13
EG005	Maintenance Treatment Period - Tralokinumab 150 Q2W	Maintenance Treatment Period - Tralokinumab 150 Q2W (n=12, PYE=6.40)	12	0	12	7	12
EG006	Maintenance Treatment Period - Tralokinumab 150 Q4W	Maintenance Treatment Period - Tralokinumab 150 Q4W (n=14, PYE=6.53)	14	0	14	8	14
EG007	Maintenance Treatment Period - Placebo	Maintenance Treatment Period - Placebo (n=6, PYE=2.98)	6	0	6	4	6
EG008	Open-label Treatment - Tralokinumab 300 Q2W + Optional TCS	Open-label Treatment - Tralokinumab 300 Q2W + optional TCS (n=234, PYE=151.12)	234	7	234	100	234
EG009	Safety Follow-up	Safety Follow-up (n=234, PYE=54.00)	234	3	234	16	234

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG0030 events0 affected11 at risk EG0040 events0 affected13 at risk EG0050 events0 affected12 at risk EG0060 events0 affected14 at risk EG0070 events0 affected6 at risk EG0081 events1 affected234 at risk EG0090 events0 affected234 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0020 events0 affected94 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0020 events0 affected94 at risk EG003
Anorexia nervosa	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Renal injury	Renal and urinary disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0021 events1 affected94 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adrenal insufficiency	Endocrine disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG0031 events1 affected11 at risk EG0040 events0 affected13 at risk EG0050 events0 affected12 at risk EG0060 events0 affected14 at risk EG0070 events0 affected6 at risk EG0080 events0 affected234 at risk EG0090 events0 affected234 at risk
Cataract	Eye disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 20.0	Non-systematic Assessment	EG0002 events2 affected97 at risk EG0012 events2 affected98 at risk EG0023 events2 affected94 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0014 events4 affected98 at risk EG0024 events4 affected94 at risk EG003
Injection site reaction	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events2 affected97 at risk EG0019 events6 affected98 at risk EG0020 events0 affected94 at risk EG003
Malaise	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0012 events1 affected98 at risk EG0020 events0 affected94 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0012 events2 affected98 at risk EG0020 events0 affected94 at risk EG003
Furuncle	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0020 events0 affected94 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0002 events2 affected97 at risk EG0012 events2 affected98 at risk EG0021 events1 affected94 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0012 events2 affected98 at risk EG0024 events4 affected94 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00011 events11 affected97 at risk EG00110 events8 affected98 at risk EG0025 events4 affected94 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00016 events12 affected97 at risk EG00122 events19 affected98 at risk EG00210 events8 affected94 at risk EG003
Inappropriate schedule of drug administration	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0020 events0 affected94 at risk EG003
Procedural anxiety	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0006 events6 affected97 at risk EG0015 events5 affected98 at risk EG0023 events3 affected94 at risk EG003
Migraine	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0004 events4 affected97 at risk EG0012 events1 affected98 at risk EG0023 events3 affected94 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected97 at risk EG0010 events0 affected98 at risk EG0021 events1 affected94 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected97 at risk EG0010 events0 affected98 at risk EG0024 events4 affected94 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0010 events0 affected98 at risk EG0020 events0 affected94 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0007 events7 affected97 at risk EG00116 events12 affected98 at risk EG00215 events11 affected94 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected98 at risk EG0020 events0 affected94 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

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 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	22.0			2-Sided	95	12.0	32.0			Mantel-Haenszel risk difference, stratified by region and baseline disease severity.		Superiority	Primary endpoint tested sequentially at a 5% significance level
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	22.5			2-Sided	95	12.4	32.6			Mantel-Haenszel risk difference, stratified by region and baseline disease severity.		Superiority	Primary endpoint tested sequentially at a 5% significance level

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 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	21.7			2-Sided	95	12.3	31.1			Mantel-Haenszel risk difference, stratified by region and baseline disease severity.		Superiority	Secondary endpoint tested sequentially at a 2.5% significance level
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	19.9			2-Sided	95	10.6	29.2			Mantel-Haenszel risk difference, stratified by region and baseline disease severity.		Superiority	Secondary endpoint tested sequentially at a 5% significance level

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 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-19.7			2-Sided	95	-27.1	-12.2					Superiority	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 and first secondary endpoint, if these showed statistical significance.
OG001 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-18.0			2-Sided	95	-25.6	-10.4					Superiority	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 and first secondary endpoint, if these showed statistical significance.

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 OG002	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.	Repeated measurements model		0.007	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-2.6			2-Sided	95	-4.5	-0.7					Superiority	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 and first secondary endpoint, if these showed statistical significance.
OG001 OG002	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.	Repeated measurements model		0.040	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-2.0			2-Sided	95	-3.9	-0.1					Superiority	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 and first secondary endpoint, if these showed statistical significance.

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 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	38.5			2-Sided	95	26.8	50.2			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	32.4			2-Sided	95	20.6	44.1			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Cochran-Mantel-Haenszel		0.002	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	13.7			2-Sided	95	5.2	22.2			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	15.3			2-Sided	95	6.5	24.1			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-9.4			2-Sided	95	-13.5	-5.3					Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-9.4			2-Sided	95	-13.6	-5.3					Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Cochran-Mantel-Haenszel		0.002	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	11.5			2-Sided	95	4.5	18.4			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	15.6			2-Sided	95	7.8	23.3			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	26.2			2-Sided	95	16.1	36.3			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	25.5			2-Sided	95	15.3	35.7			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-1.5			2-Sided	95	-2.4	-0.6					Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Repeated measurements model		0.007	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-1.2			2-Sided	95	-2.1	-0.3					Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	20.3			2-Sided	95	9.7	31.0			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Cochran-Mantel-Haenszel		<0.001	Based on the primary analysis of the primary estimand 'composite'.	Risk Difference (RD)	21.8			2-Sided	95	10.9	32.7			Mantel-Haenszel risk difference, stratified by region and disease severity.		Superiority	The statistical test was not controlled for multiplicity.

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 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-6.0			2-Sided	95	-8.4	-3.6					Superiority	The statistical test was not controlled for multiplicity.
OG001 OG002	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.	Repeated measurements model		<0.001	Based on the primary analysis of the primary estimand 'hypothetical'.	Difference of least square means	-5.4			2-Sided	95	-7.9	-3.0					Superiority	The statistical test was not controlled for multiplicity.

Title

Denominators

Categories

Title	Measurements
	OG0005.9± NA1 subject provided data at Week 66, hence coefficient of variation could not be calculated. OG0011.0± 458.0 OG0021.5± 168.6 OG0032.6± 75.6 OG0044.4± 136.5