NCT04206553

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: * Side effects that may be experienced by people taking dupilumab * How dupilumab works in the body and affects the body * How dupilumab affects quality of life * How much dupilumab is present in the blood * To see if dupilumab works to wean the patient off oral corticosteroids

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	dupilumab	Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.
DRUG	Matching Placebo	Matching dupilumab without active substance
DRUG	Oral corticosteroids (OCS)	Prednisone or prednisolone per standard of care to obtain control of disease activity.

Timeline

• Start date: 2020-10-28
• Primary completion: 2024-07-12
• Completion: 2025-01-05
• First posted: 2019-12-20
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

53 sites across 9 countries: United States, Australia, France, Germany, Israel, Japan, Poland, Spain, Taiwan

Regulatory

• FDA-regulated drug study