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Clinical Trials/EUCTR2013-001217-33-AT
EUCTR2013-001217-33-AT
Active, not recruiting
Phase 1

A randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of VAY736 in the treatment of patients with pemphigus vulgaris

ovartis Pharma Services AG0 sites32 target enrollmentOctober 3, 2013
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma Services AG
Enrollment
32
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 3, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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