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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01705795
• Date of registration: 05/10/2012
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Anti-IL-5 Therapy in Bullous Pemphigoid (BP)
• Scientific 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.
• Date of first enrolment: February 13, 2013
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01705795
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Dagmar Simon
• Affiliation: Inselspital, Bern University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pemphigoid, Bullous

Intervention(s)

Drug: Placebo

Drug: Mepolizumab (a-IL-5 antibody)

Primary Outcome(s)

Time period (in days) from start of therapy until relapse, mepolizumab vs placebo [Time Frame: Before, at 3-9 months]

Secondary Outcome(s)

Changes of BP-antibody titers over time [Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months)]

Changes of pruritus score (visual analog scale) [Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months)]

Changes of BP severity score over time (ABSIS) [Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months)]

Number of patients with AE, severity of AE [Time Frame: At baseline, during therapy (expected to be ca. 4 months), follow up (expected to be ca. 9 months)]

Secondary ID(s)

191/11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors