NCT03160885

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 794 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (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. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

Detailed description

Subjects found eligible following the screening period were randomized 3:1 to initial treatment with tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Randomization was stratified by region (Asia, Australia, Europe, and North America) and disease severity (Investigator's Global Assessment \[IGA\] 3 or 4). Subjects achieving a clinical response at Week 16 (defined as IGA of 0 or 1 on a 5-point scale ranging from 0 \[clear\] to 4 \[severe\], or at least 75% reduction in Eczema Area and Severity Index \[EASI\] score from baseline \[EASI75\]) continued into maintenance treatment that continued until Week 52. Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) were re-randomized 2:2:1 to one of the following Q2W maintenance regimens stratified by region (Asia, Australia, Europe, and North America) and IGA response at Week 16 (IGA 0/1 or IGA \>1): * Tralokinumab 300 mg Q2W. * Tralokinumab 300 mg Q4W (alternating dose administrations tralokinumab 300 mg and placebo). * Placebo. Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) continued to receive placebo Q2W in the maintenance treatment period. Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid (TCS) up to Week 52. Transfer to open-label treatment during maintenance: Subjects with IGA=0 at Week 16: IGA of at least 2 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits). Subjects with IGA=1 at Week 16: IGA of at least 3 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits). Subjects with IGA \>1 at Week 16: not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits). Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training (at 3 dosing visits in the open-label period after additional consent has been obtained) by site staff at the investigator's discretion. After completion of the maintenance treatment period (or open-label treatment), all subjects, except for those who entered the open-label long-term extension trial, continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody (ADA).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	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 (SC) administration
DRUG	Placebo	Placebo contains the same excipients, in the same concentration only lacking tralokinumab

Timeline

• Start date: 2017-06-12
• Primary completion: 2018-09-04
• Completion: 2019-08-14
• First posted: 2017-05-19
• Last updated: 2025-03-11
• Results posted: 2020-08-24

Locations

115 sites across 9 countries: United States, Australia, Canada, Denmark, Italy, Poland, Russia, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study