Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

• Conditions: Bullous Pemphigoid

• Registration Number: NCT05906706
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Key

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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified