NCT03809663

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tezepelumab	Solution for injection
OTHER	Placebo	Placebo solution for injection

Timeline

• Start date: 2019-03-15
• Primary completion: 2020-05-12
• Completion: 2020-12-22
• First posted: 2019-01-18
• Last updated: 2022-03-10
• Results posted: 2022-03-10

Locations

86 sites across 15 countries: United States, Australia, Canada, Czechia, Estonia, Germany, Hungary, Japan, Latvia, Poland, South Korea, Spain, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study