NCT01949311

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,733 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab

Timeline

• Start date: 2013-10-10
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2013-09-24
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

432 sites across 28 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, Slovakia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study