Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 20 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | December 18, 2013 |
| End Date: | January 31, 2019 |
A Randomized, Partial-blind, Placebo-controlled Trial Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of VAY736 in the Treatment of Patients With Pemphigus Vulgaris
To evaluate the safety, tolerability and efficacy of a single intravneous infusion of VAY736,
compared to placebo, in pemphigus vulgaris patients.
compared to placebo, in pemphigus vulgaris patients.
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.
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials