Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid

• Status: Not yet recruiting
• Trial end date: 2023-11-25
• Target enrollment: 0
• Participant gender: All

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 (BP) at Week 24 in patients with active moderate-to-severe BP refractory to rituximab therapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Omalizumab; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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