FindTrial
Sign In

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05906706
Enrollment
Unknown
Registered
2023-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous Pemphigoid

Keywords

Skin Diseases, Autoimmune Diseases, Immune System Diseases, Inflammatory Diseases

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.

Interventions

DRUGdupilumab

Subcutaneous (SC) administration

Sponsors

Sanofi
CollaboratorINDUSTRY
Regeneron Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Key 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/

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026