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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04128176
Phase
PHASE3
Status
Withdrawn

Conditions

  • Bullous Pemphigoid

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab combined with Omalizumab — DRUG
    Rituximab 1000 mg will be administered by IV infusion 6 months after the patient's initial cycle of rituximab (received in the screening period).Omalizumab (300 mg) will be administered subcutaneously every 2 weeks starting on Day 1 until week 24 (primary endpoint) and again until week 52 (secondary endpoint).

Study Details

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.

Key Dates

Start date
Mar 31, 2017
Status verified
Jul 2024
Primary completion
May 25, 2023
Completion
Nov 25, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab combined with Omalizumab
    All patients will receive daily doxycycline, nicotinamide, and high-potency topical steroids. Additionally, all patients will receive rituximab combined with omalizumab.

Primary Outcome Measure

Disease Remission [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis, Department of DermatologySacramentoCalifornia95816-

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University of California, Davis, Department of Dermatology· Sacramento, CA

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