PER-003-20已完成未知
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VIB4920 IN SUBJECTS WITH SJÖGREN’S SYNDROME (SS)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Population 1:
- •1.Male or female adults, 18 years or older at time of informed consent.
- •2.Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
- •3.Have an ESSDAI score of ≥ 5 at screening; the following domains are excluded and will not be scored: Peripheral nervous system, Central nervous system, and Pulmonary.
- •4.Positive for either anti-Ro autoantibodies, RF, or both at screening, as per the definition of the standard central laboratory test.
- •5.Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •6.Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from signing the informed consent form (ICF), and must agree to continue using such precautions through the end of the study follow-up; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method will be made.
- •Population 2:
- •1.Male or female adults, 18 years old or older at time of informed consent.
- •2.Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
- •3.Have an ESSPRI score of ≥ 5 at screening.
- •4.Have an ESSDAI score of < 5 at screening.
- •5.Positive for either anti-Ro autoantibodies or RF, or both at screening, as per the definition of the standard central laboratory test available.
- •6.Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
- •7.Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States, EU Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •8.Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from signing the ICF, and must agree to continue using such precautions through the end of the follow up of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation that the female partners (of child bearing potential) of male study participants should use a highly effective method of contraception other than a barrier method will be made.
排除标准
- •Population 1:
- •1.Patients with medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of enrollment.
- •2. Patients with risk factors for venous thromboembolism or arterial thrombosis (eg, immobilization or major surgery within 12 weeks before screening), prothrombotic status (including, but not limited to, congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of catastrophic antiphospholipid syndrome).
- •3. Patients requiring treatment with anticoagulant drugs (clopidogrel, prasugrel, warfarin, low molecular weight heparin, others). Low-dose aspirin treatment (up to 325 mg/day) is allowed.
- •4. Concomitant polymyositis or dermatomyositis or systemic sclerosis.
- •5. Active malignancy or history of malignancy, except as follows:
- •a. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; or
- •b. Cutaneous basal cell carcinoma following apparently curative therapy.
- •6. Subjects who are pregnant or lactating or planning to become pregnant during the duration of the study.
- •Population 2:
- •1. Patients with medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of enrollment.
- •2. Patients with risk factors for venous thromboembolism or arterial thrombosis (eg, immobilization or major surgery within 12 weeks before screening), prothrombotic status (including, but not limited to, congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of catastrophic antiphospholipid syndrome).
- •3. Patients requiring treatment with anticoagulant drugs (clopidogrel, prasugrel, warfarin, low molecular weight heparin, etc). Low-dose aspirin treatment (up to 325 mg/day) is allowed.
- •4. Concomitant polymyositis or dermatomyositis or systemic sclerosis.
- •5. Active malignancy or history of malignancy, except as follows:
- •a. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; or
- •b. Cutaneous basal cell carcinoma treated with apparent success with curative therapy
- •6. Subjects who are pregnant or lactating or planning to get pregnant during the duration of the study.
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