NCT03363854

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

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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: 2018-02-22
• Primary completion: 2019-03-08
• Completion: 2019-09-26
• First posted: 2017-12-06
• Last updated: 2025-03-11
• Results posted: 2021-01-14

Locations

66 sites across 8 countries: United States, Belgium, Canada, Germany, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study