APPROVED_FOR_MARKETINGNot Applicable

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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
✕. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
✕. Treatment with BP-directed biologics, as defined in the protocol
✕. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
✕. Planned or anticipated use of any prohibited medications or procedures during program treatment
✕. Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

Trial details

NCT IDNCT05906706

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Bullous Pemphigoid trials