NCT03761537

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (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 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.

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

Timeline

• Start date: 2018-12-13
• Primary completion: 2020-04-21
• Completion: 2020-09-28
• First posted: 2018-12-03
• Last updated: 2025-03-11
• Results posted: 2021-10-26

Locations

74 sites across 7 countries: Belgium, Czechia, France, Germany, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study