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

Conditions

• Bullous Pemphigoid

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Oct 28, 2020

Status verified

Feb 2026

Primary completion

Jul 12, 2024

Completion

Jan 5, 2025

Study Design

Enrollment

106 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: dupilumab
• Experimental: Matching placebo

Primary Outcome Measure

Percent of Participants Achieving Sustained Remission at Week 36 [ Time Frame: At Week 36 ]

Locations (15)

Find similar trials in Birmingham, AL

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• Autoimmune Blistering Diseases Study
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