CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled / 106 target
Drug / intervention
dupilumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04206553
NCT04206553Phase 2CompletedMonitor (1.6/mo)Completion was 23mo ago
CompareCT.gov

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

Regeneron Pharmaceuticals·interventional·Posted Dec 20, 2019·Updated Jun 18, 2026

In Brief

A Phase 2 clinical trial evaluating dupilumab, Matching Placebo, and 1 other intervention for Bullous Pemphigoid. Completed, enrolled 106 participants across 53 sites in 9 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBullous Pemphigoid
CountriesAustralia, France, Germany, Israel, Japan, Poland, Spain, Taiwan, United States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 20, 2019
Enrollment StartOct 28, 2020
Primary CompletionJul 12, 2024
Study CompletionJan 5, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.5 years ago

Arms & Interventions

dupilumabexperimental

Drug: dupilumabDrug: Oral corticosteroids (OCS)
Matching placeboexperimental

Drug: Matching PlaceboDrug: Oral corticosteroids (OCS)

Interventions

dupilumabdrug

Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.

Matching Placebodrug

Matching dupilumab without active substance

Oral corticosteroids (OCS)drug

Prednisone or prednisolone per standard of care to obtain control of disease activity.