Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

LEO Pharma380 enrolled

Overview

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). 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 with placebo in combination with TCS. To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Atopic Dermatitis

Interventions

TralokinumabDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * Subjects who have a recent history of inadequate response to treatment with topical medications. * 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: * Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator. * 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, topical calcineurin inhibitors (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 within 3 months or 5 half-lives, whichever is longer prior to randomisation. * 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.

Locations (66)

Outcomes

Primary Outcomes

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

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

Time frame: Week 16

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

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

Time frame: Week 16

Secondary Outcomes

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

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

Time frame: Week 0 to Week 16

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

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

Time frame: Week 0 to Week 16

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

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

Time frame: Week 0 to Week 16

Data from ClinicalTrials.gov

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University of Alabama-Birmingham

Birmingham, Alabama, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology

Fountain Valley, California, United States

Center for Dermatology Clinical Research

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Clinical Science Institute

Santa Monica, California, United States

Danbury Clinical Research

Danbury, Connecticut, United States

International Dermatology Research

Miami, Florida, United States

L & C Professional Medical Research

Miami, Florida, United States

Lenus Research & Medical Group

Sweetwater, Florida, United States

...and 56 more locations

Frequency of Anti-drug Antibodies (ADA)

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

Time frame: Week 0 to Week 16, Week 16 to Week 32

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

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

Time frame: Week 1-2 to Week 15-16

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

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

Time frame: Week 1-2 to Week 15-16

Number of Atopic Dermatitis Flares Through Week 16

Assessed as appearance of new flares since previous visit.

Time frame: Week 0 to Week 16

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

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

Time frame: Week 1 to Week 16

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

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

Time frame: Week 16

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

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

Time frame: Week 16

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

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

Time frame: Week 0 to Week 16

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

Time frame: Week 16

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

Time frame: Week 16

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

Time frame: Week 0 to Week 16

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

Time frame: Week 0 to Week 16

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

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

Time frame: Week 32

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

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

Time frame: Week 32