Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)
Key Exclusion Criteria:
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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
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Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
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Treatment with BP-directed biologics, as defined in the protocol
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Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
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Planned or anticipated use of any prohibited medications or procedures during program treatment
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Sanofi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R668-BP-2290-EAP