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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT04128176
• Date of registration: 12/10/2019
• Prospective Registration: Yes
• Primary sponsor: University of California, Davis
• Public title: Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
• Scientific title: An Open-Label Study to Evaluate the Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
• Date of first enrolment: May 25, 2023
• Target sample size: 15
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04128176
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Stephanie T Le, MD

• Name: Emanual Maverakis, MD
• Affiliation: UC Davis

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bullous Pemphigoid

Intervention(s)

Drug: Rituximab combined with Omalizumab

Primary Outcome(s)

Disease Remission [Time Frame: 24 weeks]

Secondary Outcome(s)

Clinical Impression [Time Frame: 52 weeks]

Health-Related Quality of Life [Time Frame: 52 weeks]

Number of Disease Flares [Time Frame: 52 weeks]

Patient Impression [Time Frame: 52 weeks]

Improvement in Itch [Time Frame: 52 weeks]

Time to Flares [Time Frame: 52 weeks]

Disease Remission [Time Frame: 52 weeks]

Duration of Remission [Time Frame: 52 weeks]

Time to Remission [Time Frame: 52 weeks]

Secondary ID(s)

1510820

Source(s) of Monetary Support

Please refer to primary and secondary sponsors