Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid

NCT05906706•Regeneron Pharmaceuticals

Summary

The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

Detailed Description

Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)

Exclusion Criteria

•1. Patients who, during the parent dupilumab study, R668-BP-1902 (NCT04206553), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to program drug and which led to discontinuation of investigational product
•2. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
•3. Treatment with BP-directed biologics, as defined in the protocol
•4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
•5. Planned or anticipated use of any prohibited medications or procedures during program treatment
•6. Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

Key Dates

Last Updated

July 3, 2025

Conditions

Bullous Pemphigoid

Interventions

dupilumab

DRUG

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

NCT06371417

Antiphospholipid Syndrome (APS)Bullous Pemphigoid (BP)+4 more

View study

RECRUITING

Autoimmune Blistering Diseases Study

NCT02753777

Pemphigus VulgarisPemphigus Foliaceus+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

Inclusion Criteria

Exclusion Criteria

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Autoimmune Blistering Diseases Study

Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid