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NCT05906706 Clinical Trial

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05906706
Other study ID # R668-BP-2290-EAP
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Regeneron Pharmaceuticals
Contact Requests for compassionate use must be initiated by a treating p
Phone 844-734-6643
Email CompassionateUse_Requests@regeneron.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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/exclusion criteria apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dupilumab
Subcutaneous (SC) administration

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals Sanofi
See also
  Status Clinical Trial Phase
Terminated NCT03286582 - A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid Phase 2
Completed NCT02837965 - Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid
Recruiting NCT03636763 - Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?
Recruiting NCT00802243 - Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid Phase 2
Completed NCT05649579 - Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
Active, not recruiting NCT04206553 - A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid Phase 2/Phase 3
Completed NCT00431119 - Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid Phase 2
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Not yet recruiting NCT04128176 - Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid Phase 3
Recruiting NCT05284929 - Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Terminated NCT04612790 - A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. Phase 3
Recruiting NCT05681481 - A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid Phase 3
Completed NCT00286325 - Rituximab in the Treatment of Patients With Bullous Pemphigoid Phase 1/Phase 2
Completed NCT04728854 - Telederm and Bullous Pemphigoid