drugset
drugset / Trial / NCT04587453

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

NCT04587453 ↗

Phase 3 Completed 106 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-10-27
Primary completion
2021-07-06
Completion
2021-07-15

Outcome

Missed primary endpoint

registry analysis (other test); Tralokinumab+TCS vs Placebo+TCS; Risk Difference (RD) 5.7 (95% CI -11.2 to 22.5) NCT04587453 ↗

registry analysis (other test); Tralokinumab+TCS vs Placebo+TCS; Risk Difference (RD) 15.1 (95% CI -2.9 to 33.0) NCT04587453 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tralokinumab Monoclonal antibody — Subcutaneous

Indications

atopic eczema