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

NCT01705795 | Completed Phase 2 DMC

• 1 other identifier: 191/11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pemphigoid, Bullous

Outcome Measures

Primary Outcomes (1)

• Time period (in days) from start of therapy until relapse, mepolizumab vs placebo

  Before, at 3-9 months

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Mepolizumab

ACTIVE COMPARATOR

Mepolizumab 750 mg four times one month apart.

Drug: Mepolizumab (a-IL-5 antibody)

Placebo

PLACEBO COMPARATOR

Placebo (saline) four times one month apart

Drug: Placebo

Interventions

Mepolizumab (a-IL-5 antibody) DRUG

750mg mepolizumab four times over four months

Mepolizumab

Placebo DRUG

Nacl four times over four months

Placebo

Eligibility Criteria

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

You may qualify if:

• Men, women \>18 years
• Active BP (diagnosed by typical clinical picture and skin biopsy)
• Must give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Dermatology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Dagmar Simon

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 12, 2012
• Study Start: February 13, 2013
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

CH (1)