Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

NCT05906706 | Unknown

• 1 other identifier: R668-BP-2290-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bullous Pemphigoid

Keywords

Skin Diseases; Autoimmune Diseases; Immune System Diseases; Inflammatory Diseases

Interventions

dupilumab DRUG

Subcutaneous (SC) administration

Also known as: REGN668, DUPIXENT®, SAR231893

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
• Treatment with BP-directed biologics, as defined in the protocol
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
• Planned or anticipated use of any prohibited medications or procedures during program treatment
• Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Pemphigoid, Bullous; Skin Diseases; Autoimmune Diseases; Immune System Diseases

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin and Connective Tissue Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06