Status:
WITHDRAWN
Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
Lead Sponsor:
University of California, Davis
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of rituximab combined with omalizumab in achieving sustained complete remission, evaluated by Bullous Pemphigoid Disease Area Index (BPDAI) in patients with bullous pemphigoid...
Detailed Description
This is an open-label, noncontrolled, single center prospective study to evaluate the efficacy and safety of rituximab combined with omalizumab in patients with active moderate-to-severe BP refractory...
Eligibility Criteria
Inclusion
- Patients must be 18-90 years of age
- All individuals must have the ability to provide inform consent
- Patients diagnosed with bullous pemphigoid by biopsy, serum ELISA, direct immunofluorescence, indirect immunofluorescence
- Presence of moderate-to-severe active disease refractory to at least one cycle of rituximab therapy
Exclusion
- Diagnosis of mucous membrane pemphigoid or evidence of other non-BP autoimmune blistering disease
- Individuals with allergic reaction or adverse reaction to humanized or murine monoclonal antibodies, or known hypersensitivity to any component of rituximab or omalizumab
- Evidence of acute infection or history of a chronic infection including viral hepatitis, recurrent HSV, AIDS, etc
- Women who are pregnant or actively nursing
- Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude patient participation, including but not limited to cardiovascular, pulmonary, nervous system, renal, hepatic, endocrine, malignant, or gastrointestinal disorders
- Treatment with a live or attenuated vaccine within 28 days prior to first rituximab infusion
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04128176
Start Date
March 1 2017
End Date
November 25 2023
Last Update
July 3 2024
Active Locations (1)
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1
University of California, Davis, Department of Dermatology
Sacramento, California, United States, 95816