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 个研究点目标入组 32 人开始时间: 2013年10月3日最近更新: 2019年12月10日

试验速览

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•- 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

•- 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.

发起方