NCT04587453

Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with 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, health-related quality of life, and health care resource utilisation 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 16 weeks.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tralokinumab	Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
DRUG	Placebo	Placebo contains the same excipients in the same concentration only lacking tralokinumab.
OTHER	Topical corticosteroids (TCS)	TCS administered as needed.

Timeline

• Start date: 2020-10-27
• Primary completion: 2021-07-06
• Completion: 2021-07-15
• First posted: 2020-10-14
• Last updated: 2025-03-11
• Results posted: 2022-09-22

Locations

25 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study