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Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 (ECZTRA 7)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tralokinumab

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Age 18 and above
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
History of AD for 1 year or more
Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Key Exclusion Criteria:

Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
History of any active skin infection within 1 week prior to randomisation
History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tralokinumab + TCS

Placebo + TCS

Arm Description

4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Outcomes

Primary Outcome Measures

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16

EASI (Eczema Area and Severity Index) 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

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16

Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16

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 Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16

DLQI 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 different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

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

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 Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26

Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26

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 Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26

Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26

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).

Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40

Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.

Number of Adverse Events From Week 0 to Week 40

All adverse events are presented below under Adverse Events

Full Information

NCT ID

NCT03761537

First Posted

November 30, 2018

Last Updated

May 10, 2023

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03761537

Brief Title

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

Acronym

ECZTRA 7

Official Title

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 13, 2018 (Actual)

Primary Completion Date

April 21, 2020 (Actual)

Study Completion Date

September 28, 2020 (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

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

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

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tralokinumab + TCS

Arm Type

Experimental

Arm Description

Arm Title

Placebo + TCS

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tralokinumab

Intervention Description

Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16

Description

Time Frame

Week 0 to Week 16

Secondary Outcome Measure Information:

Title

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16

Description

Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Time Frame

Week 0 to Week 16

Title

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16

Description

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

Week 0 to Week 16

Title

Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16

Description

Time Frame

Week 0 to Week 16

Title

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

Description

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

Week 16

Title

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26

Description

Time Frame

Week 0 to Week 26

Title

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26

Description

Time Frame

Week 0 to Week 26

Title

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26

Description

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

Week 0 to Week 26

Title

Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26

Description

Time Frame

Week 0 to Week 26

Title

Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26

Description

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

Week 26

Title

Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40

Description

Time Frame

Week 0 to Week 40

Title

Number of Adverse Events From Week 0 to Week 40

Description

All adverse events are presented below under Adverse Events

Time Frame

Week 0 to Week 40

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Age 18 and above Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD History of AD for 1 year or more Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation Key Exclusion Criteria: Subjects for whom TCSs are medically inadvisable in the opinion of the investigator Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer History of any active skin infection within 1 week prior to randomisation History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

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 Investigationel Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Gent

ZIP/Postal Code

B-9000

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Herstal

ZIP/Postal Code

B-4040

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Loverval

ZIP/Postal Code

6280

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Maldegem

ZIP/Postal Code

9990

Country

Belgium

Facility Name

Leo Pharma Investigationel Site

City

Karlovy Vary

ZIP/Postal Code

36001

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Kutna Hora

ZIP/Postal Code

284 01

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Ostrava

ZIP/Postal Code

70852

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Prague 5

ZIP/Postal Code

15006

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Prague 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Prague

ZIP/Postal Code

11000

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Prague

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Leo Pharma Investigationel Site

City

Grenoble

ZIP/Postal Code

38000

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Valence

ZIP/Postal Code

26000

Country

France

Facility Name

Leo Pharma Investigationel Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Berlin

ZIP/Postal Code

10117,

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Dülmen

ZIP/Postal Code

48249

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Halle

ZIP/Postal Code

06097

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Hanover

ZIP/Postal Code

30159

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Mainz

ZIP/Postal Code

55128

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

München

ZIP/Postal Code

80337

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Selters

ZIP/Postal Code

56242

Country

Germany

Facility Name

Leo Pharma Investigationel Site

City

Białystok

ZIP/Postal Code

15-375

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Bochnia

ZIP/Postal Code

32-700

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Gdańsk

ZIP/Postal Code

80-546

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

31-530

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Kraków

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Poznań

ZIP/Postal Code

60-369

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Rzeszów

ZIP/Postal Code

35-312

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Warszawa

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Warszawa

ZIP/Postal Code

02-625

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Warszawa

ZIP/Postal Code

02-953

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Wrocław

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Łódź

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Łódź

ZIP/Postal Code

90-752

Country

Poland

Facility Name

Leo Pharma Investigationel Site

City

Granada

State/Province

Andalucía

ZIP/Postal Code

18014

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Sevilla

ZIP/Postal Code

41007

Country

Spain

Facility Name

Leo Pharma Investigationel Site

City

Bradford

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

Cottingham

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

Kirkcaldy

ZIP/Postal Code

KY2 5AH

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Leo Pharma Investigationel Site

City

Wakefield

ZIP/Postal Code

WF1 4DG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

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Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7 (ECZTRA 7)

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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