drugset
drugset / Trial / NCT03761537

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

NCT03761537 ↗

Phase 3 Completed 277 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-12-13
Primary completion
2020-04-21
Completion
2020-09-28

Outcome

Met primary endpoint

registry NUMBER Tralokinumab+TCS: 64.2 Percentage of responders NUMBER Placebo+TCS: 50.5 Percentage of responders NCT03761537 ↗

registry analysis (superiority test); Tralokinumab+TCS vs Placebo+TCS; p = 0.018; Risk Difference (RD) 14.1 (95% CI 2.5 to 25.7); NCT03761537 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tralokinumab Monoclonal antibody 150 mg Subcutaneous

Indications

atopic eczema