Anti-IL-5 Therapy in Bullous Pemphigoid (BP)

• Status: Completed
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, placebo-controlled, double-blind study evaluating the effect of anti-IL-5-therapy in patients with bullous pemphigoid. The primary study objective is to determine the efficacy of an anti-IL-5 monoclonal antibody therapy, administered as 750mg mepolizumab, in patients with bullous pemphigoid.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Antibodies

Criteria

Inclusion Criteria:

• Men, women >18 years

• Active BP (diagnosed by typical clinical picture and skin biopsy)

• Must give written informed consent

Exclusion Criteria

• Patients with other skin disease

• Patients with severe diseases of other organ systems

• Systemic treatment for BP

• Topical therapy with corticosteroids and other anti-inflammatory substances

• For female patients, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception (defined as methods with <1% failure rate)

• Female patients who are currently pregnant or breast-feeding

• Current abuse of alcohol and/or drugs

• History of or a new diagnosis or treatment of an invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.

• History of recurrent clinically significant infection

• Congenital or acquired immunodeficiency syndrome

• Current enrollment in any other investigational drug study

• Previous participation in this study or previous studies with mepolizumab

• Hypersensitivity to mepolizumab or its constituents