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

NCT04128176 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 1510820
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Bullous Pemphigoid

Keywords

Omalizumab; Rituximab; Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Disease Remission

  Complete remission is defined as achieving wound healing with no new active lesions (i.e. Bullous Pemphigoid Disease Area Index (BPDAI) score of 0) for at least 2 consecutive weeks during the 24-week treatment period. BPDAI scores can range from 0 to 360, with lower scores indicating less disease activity and better outcomes.

  24 weeks

Secondary Outcomes (9)

• Disease Remission

  52 weeks

• Number of Disease Flares

  52 weeks

• Time to Remission

  52 weeks

• Time to Flares

  52 weeks

• Duration of Remission

  52 weeks

Other Outcomes (3)

• Adverse Events That Are Related to Treatment

  52 weeks

• Gene Expression

  52 weeks

• Cumulative Corticosteroid Application

  52 weeks

Study Arms (1)

Rituximab combined with Omalizumab

EXPERIMENTAL

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

Drug: Rituximab combined with Omalizumab

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).

Also known as: Xolair

Rituximab combined with Omalizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (2)

• Ujiie H, Nishie W, Shimizu H. Pathogenesis of bullous pemphigoid. Dermatol Clin. 2011 Jul;29(3):439-46, ix. doi: 10.1016/j.det.2011.03.008.

  PMID: 21605809 BACKGROUND

• Maglie R, Hertl M. Pharmacological advances in pemphigoid. Curr Opin Pharmacol. 2019 Jun;46:34-43. doi: 10.1016/j.coph.2018.12.007. Epub 2019 Feb 13.

  PMID: 30769277 BACKGROUND

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Emanual Maverakis, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 16, 2019
• Study Start: March 1, 2017
• Primary Completion: May 25, 2023
• Study Completion: November 25, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)