Study of efficacy and safety of VAY736 in patients with Pemphigus vulgaris

Phase 1

• Conditions: Pemphigus vulgaris; MedDRA version: 20.0 Level: LLT Classification code 10052802 Term: Pemphigus vulgaris System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-001217-33-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- Adult patients 20 to 70 years of age
- Confirmed diagnosis of pemphigus vulgaris
- Presence of mild to moderate pemphigus vulgaris
- Patients must weight between 40 kg and 150 kg inclusive
- on a stable dose of oral corticosteriod therapy (with or without azathioprine or mycophenolate)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using a highly effective method of birth control during dosing and for 4 months following study treatment
- Recent previous treatment with photo therapy, biological therapy, steroids, immunosuppresive agents (unless washout period applied)
- Active or recent history of clinically significant infection
- use of rituximab within 1 year

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified