Overview

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

Status:
Recruiting
Trial end date:
2023-09-15
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP). The secondary objectives of the study are: - To evaluate the OCS-sparing effects of dupilumab in patients with BP - To evaluate the effect of dupilumab on itch in patients with BP - To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP - To evaluate the effect of dupilumab in circulating BP180 and BP230 autoantibody titers - To assess the safety and tolerability of dupilumab administered to patients with BP - To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP - To assess the immunogenicity of dupilumab in patients with BP over time
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Treatments:
Antibodies, Monoclonal