A single dose, double-blind, placebo-controlled, parallel study to assess the pharmacodynamics, pharmacokinetics and safety and tolerability of VAY736 in patients with primary Sjögren’s syndrome - CVAY736X2201

ovartis Pharma Services AG0 个研究点目标入组 28 人开始时间: 2013年10月16日最近更新: 2018年2月26日

试验速览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed
•2. Male and female subjects age 18 to 75 years of age included
•3. Fulfilled revised European US consensus criteria for pSS (Vitali et al 2002); if key inclusion criteria are missing from medical history, information will be obtained at screening and may be used as a baseline value if required
•4. ESSDAI value = 6
•5. Elevated serum titers at screening of ANA (= 1:160) and of RF
•Seropositive at screening for anti-SSA (± anti-SSB) antibodies
•6. Stimulated whole salivary flow rate at screening of > 0 mL/min
•7. Subjects must weigh at least 50 kg and no more than 150 kg to
•participate in the study, and must have a body mass index (BMI) within
•the range of 18 - 35 kg/m2
•8. Able to communicate well with the investigator, to understand and
•comply with the requirements of the study.
•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 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-a mAb, cyclophosphamide, methotrexate, azathioprine and medications known to cause dry mouth. Hydroxychloroquine or methotrexate in a consistent dose for = 3 months prior to randomization is allowed.
•- Active or recent history of clinically significant infection
•- Vaccination within 2 month prior to study
•- History of primary or secondary immunodeficiency
•- Other protocol-defined inclusion/exclusion criteria may apply.

发起方