Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris

• Status: Terminated
• Trial end date: 2019-09-25
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of patients with pemphigus vulagaris (PV).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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)

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.