ONO-4915-02: A Phase II multicenter, placebo-controlled, randomized, double-blind, parallel-group study in patients with primary Sjogren's disease to evaluate the efficacy and safety of subcutaneously administered ONO-4915

未提供0 个研究点目标入组 60 人开始时间: 待定

适应症

试验速览

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•Age (at the time of informed consent): >=18 and <75 years
•Patients who meet the criteria for primary Sjogrens disease defined by the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
•Patients with positive anti-SS-A/Ro antibody in the screening period
•Patients with EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) score of >=5 and dry symptom score of >=5 in the screening period
•Patients with stimulated salivary secretion rate of >=0.1 mL/min by the Saxon test in the screening period.
•Patients diagnosed with primary Sjogren's disease within 10 years

•Patients with other concurrent autoimmune diseases
•Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms
•Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease
•Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease
•Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease
•Patients with current malignancy or history of malignancy within 5 years before the start of screening
•Patients with active infection

发起方

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