Pemphigoid, Bullous Clinical Trial
Official title:
Anti-IL-5 Therapy in Bullous Pemphigoid. Randomized, Placebo-controlled, Double-blind Study Evaluating the Effect of Anti-IL-5 Therapy in Patients With Bullous Pemphigoid.
Verified date | February 2017 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 31, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Dermatology, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time period (in days) from start of therapy until relapse, mepolizumab vs placebo | Before, at 3-9 months | ||
Secondary | Changes of BP severity score over time (ABSIS) | At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) | ||
Secondary | Changes of pruritus score (visual analog scale) | At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) | ||
Secondary | Changes of BP-antibody titers over time | At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) | ||
Secondary | Number of patients with AE, severity of AE | At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months) |
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