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Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tralokinumab

Placebos

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 12 to 17.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
History of AD for ≥1 year.
History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
AD involvement of ≥10% body surface area at screening and baseline.
Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Exclusion Criteria:

Active dermatologic conditions that may confound the diagnosis of AD.
Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents.
Active skin infection within 1 week prior to randomisation.
Clinically significant infection within 4 weeks prior to randomisation.
A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
Tuberculosis requiring treatment within the 12 months prior to screening.
Known primary immunodeficiency disorder.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

Placebo initial-> Placebo maintenance

Tralokinumab (Dose1) initial-> Open-label tralokinumab

Tralokinumab (Dose2) initial-> Open-label tralokinumab

Placebo initial-> Open-label tralokinumab

Arm Description

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.

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.

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 52 (maintenance period): Placebo continuation SC injection regimen A.

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: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

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: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 52: Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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'.

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.

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.

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.

Presence of Anti-drug Antibodies

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

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

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

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

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.

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

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'.

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'.

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.

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 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 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

Tralokinumab Serum Trough Concentration at Week 66

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

Full Information

NCT ID

NCT03526861

First Posted

May 4, 2018

Last Updated

May 3, 2023

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03526861

Brief Title

Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Official Title

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 19, 2018 (Actual)

Primary Completion Date

April 15, 2020 (Actual)

Study Completion Date

March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded healthcare professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA

Arm Type

Experimental

Arm Description

Arm Title

Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB

Arm Type

Experimental

Arm Description

Arm Title

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA

Arm Type

Experimental

Arm Description

Arm Title

Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB

Arm Type

Experimental

Arm Description

Arm Title

Placebo initial-> Placebo maintenance

Arm Type

Experimental

Arm Description

Week 0 to 16 (initial period): Placebo loading SC injection on Day 0 followed by placebo injection regimen A. Week 16 to 52 (maintenance period): Placebo continuation SC injection regimen A.

Arm Title

Tralokinumab (Dose1) initial-> Open-label tralokinumab

Arm Type

Experimental

Arm Description

Arm Title

Tralokinumab (Dose2) initial-> Open-label tralokinumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo initial-> Open-label tralokinumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tralokinumab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Placebo

Intervention Description

Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At Week 16

Title

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

Description

Time Frame

At Week 16

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

At Week 16

Title

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

Description

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

Time Frame

From Week 0 to Week 16

Title

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

Description

Time Frame

From Week 0 to Week 16

Title

Number of Adverse Events

Description

Time Frame

From Week 0 to Week 16

Title

Presence of Anti-drug Antibodies

Description

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

Time Frame

From Week 0 to Week 16

Title

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

Description

Time Frame

At Week 16

Title

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

Description

Time Frame

At Week 16

Title

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

Description

Time Frame

From Week 0 to Week 16

Title

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

Description

Time Frame

At Week 16

Title

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

Description

Time Frame

At Week 16

Title

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

Description

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

Time Frame

From Week 0 to Week 16

Title

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

Description

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

Time Frame

At Week 16

Title

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

Description

Time Frame

From Week 0 to Week 16

Title

Tralokinumab Serum Trough Concentration at Week 16

Description

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

Time Frame

At Week 16

Title

Description

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

Time Frame

At Week 52

Title

Description

Time Frame

At Week 52

Title

Tralokinumab Serum Trough Concentration at Week 66

Description

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

Time Frame

At Week 66

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 12 to 17. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. History of AD for ≥1 year. History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable. AD involvement of ≥10% body surface area at screening and baseline. Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation. Exclusion Criteria: Active dermatologic conditions that may confound the diagnosis of AD. Use of tanning beds or phototherapy within 6 weeks prior to randomisation. Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation. Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation. Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents. Active skin infection within 1 week prior to randomisation. Clinically significant infection within 4 weeks prior to randomisation. A helminth parasitic infection within 6 months prior to the date informed consent is obtained. Tuberculosis requiring treatment within the 12 months prior to screening. Known primary immunodeficiency disorder.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical expert

Organizational Affiliation

LEO Pharma

Official's Role

Study Director

Facility Information:

Facility Name

LEO Pharma Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Leo Pharma Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

LEO Pharma Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94132

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

LEO Pharma Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8059

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Leo Pharma Investigational Site

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48103

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

LEO Pharma Investigational Site

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Corning

State/Province

New York

ZIP/Postal Code

14830

Country

United States

Facility Name

Leo Pharma Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

LEO Pharma Investigational Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Bexley

State/Province

Ohio

ZIP/Postal Code

43209

Country

United States

Facility Name

Leo Pharma Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Leo Pharma Investigational Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Facility Name

Leo Pharma Investigational Site

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

LEO Pharma Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Leo Pharma Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Leo Pharma Investigationel Site

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Facility Name

Leo Pharma Investigationel Site

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Leo Pharma Investigationel Site

City

Melbourne

ZIP/Postal Code

3002

Country

Australia

Facility Name

Leo Pharma Investigationel Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Leo Pharma Investigationel Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Gent

ZIP/Postal Code

B-9000

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Leo Pharma Investigational Site

City

Maldegem

ZIP/Postal Code

9990

Country

Belgium

Facility Name

LEO Pharma Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3A 2N1

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1C9

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 1T6

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M 3Z4

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5A 3R6

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 2G1

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

LEO Pharma Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Leo Pharma Investigationel Site

City

Marseille

ZIP/Postal Code

13285

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Valence

ZIP/Postal Code

26000

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Jena

ZIP/Postal Code

49074

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Kagoshima city

ZIP/Postal Code

890-8520

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Nagoya-shi

ZIP/Postal Code

457-8510

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Obihiro

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Osaka-fu

ZIP/Postal Code

560-0085

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Osaka

ZIP/Postal Code

593-8324

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Shimotsuke

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Tokyo

ZIP/Postal Code

136-0074

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Tokyo

ZIP/Postal Code

169-0075

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Tokyo

ZIP/Postal Code

171-0022

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Tsu

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Yamanashi

ZIP/Postal Code

400-8506

Country

Japan

Facility Name

Leo Pharma Investigationel Site

City

Bergen Op Zoom

ZIP/Postal Code

4708

Country

Netherlands

Facility Name

Leo Pharma Investigationel Site

City

Breda

ZIP/Postal Code

4818

Country

Netherlands

Facility Name

Leo Pharma Investigationel Site

City

Groningen

ZIP/Postal Code

9713

Country

Netherlands

Facility Name

Leo Pharma Investigationel Site

City

Rotterdam

ZIP/Postal Code

3015

Country

Netherlands

Facility Name

Leo Pharma Investigationel Site

City

Kraków

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Kraków

ZIP/Postal Code

30-149

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Kraków

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Rzeszów

ZIP/Postal Code

35-055

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Wrocław

ZIP/Postal Code

50-001

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Wrocław

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Wrocław

ZIP/Postal Code

52-416

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Łódź

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Łódź

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

IPD Sharing Time Frame

Data are available to request after results of the trial are available on leopharmatrials.com.

IPD Sharing Access Criteria

Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

IPD Sharing URL

http://leopharmatrials.com/for-professionals

Citations:

PubMed Identifier

37074705

Citation

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. Erratum In: JAMA Dermatol. 2023 Jun 1;159(6):673.

Results Reference

result

PubMed Identifier

35671038

Citation

Soehoel A, Larsen MS, Timmermann S. Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clin Pharmacol Drug Dev. 2022 Aug;11(8):910-921. doi: 10.1002/cpdd.1113. Epub 2022 Jun 7.

Results Reference

derived

Learn more about this trial

Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

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Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial