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

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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.


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
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Vienna,
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