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A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis

Clinical Trial Summary

This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe atopic dermatitis (AD).

Clinical Trial Description

All subjects will receive a subcutaneous (SC) dose of either investigational product or placebo as the first dose on day 1. Subjects who are determined to be non-responders in Part A will receive tezepelumab SC every 2 weeks (Q2W) following completion of all week 16 study activities. Nonresponders are defined as those subjects who have not achieved at least a 50% improvement in Eczema Area and Severity Index (EASI) at week 16 compared to baseline (day 1). Safety follow-up is 18 weeks after the end of treatment (EOT) visit (20 weeks after the final dose of investigational product). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03809663
Study type Interventional
Source Amgen
Contact
Status Terminated
Phase Phase 2
Start date March 15, 2019
Completion date December 22, 2020
View Details
See also
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