Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

NCT ID: NCT05906706

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Detailed Description

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

Conditions

Bullous Pemphigoid

Interventions

dupilumab

Subcutaneous (SC) administration

Intervention Type: DRUG

Other Intervention Names

REGN668; DUPIXENT®; SAR231893

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R668-BP-2290-EAP

Identifier Type: -

Identifier Source: org_study_id