CTRI/2020/09/027969已完成2 期
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) - Not applicable
试验速览
- 阶段
- 2 期
- 状态
- 已完成
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
- •Inclusion criteria for Population 1-
- •1.Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
- •2.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.
- •Inclusion criteria for Population 2-
- •1.Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria.
- •2.Have an ESSPRI score of = 5 at screening.
- •3.Have an ESSDAI score of < 5 at screening.
- •Inclusion criteria common for both Population 1 & 2
- •1.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 lrelated procedures, including screening evaluations.
- •2.Positive for either anti-Ro autoantibodies, RF, or both at screening, as per the definition of the standard central laboratory test.
- •3.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.
- •a. Females of childbearing potential are defined as those who are not surgically sterile (surgical sterilization includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).
- •4.Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through the end of the study.
- •5.Meets all of the following tuberculosis (TB) criteria:
- •a. No history of latent or active TB prior to screening, with the exception of latent TB with documented completion of appropriate treatment.
- •b. No signs or symptoms suggestive of active TB from medical history or physical examination.
- •c. No recent (= 12 weeks of screening) close contact with a person with active TB (close contact is defined as = 4 hours/week OR living in the same household OR in a house
- •where a person with active TB is a frequent visitor).
- •d. Negative Interferon Gamma Release Assay (IGRA) test result for TB obtained within 12 weeks prior to randomization. Subjects with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
- •e. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to signing of the ICF) with no evidence of current active TB or other infection, or old active TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).
排除标准
- •Exclusion criteria for Population 1
- •Details Exclusion criteria for Population 1:
- •1.Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization. Concomitant treatment with oral corticosteroids = 10 mg/day prednisone or equivalent is permitted provided that the dose is stable = 2 weeks prior to screening through randomization (Day 1) and is expected to remain stable for the duration of the treatment period. Inhaled or topical corticosteroids given for asthma, chronic obstructive pulmonary disease or
- •dermatological conditions are allowed provided doses are expected to be stable during the study.
- •2.Subjects treated with systemic corticosteroids for indications other than SS for more than a total of 2 weeks within 24 weeks prior to ICF signature.
- •3.Use of the following medications:
- •a. Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) if they have been initiated or if the dose has changed within 8 weeks prior to signing the ICF or during the screening period.
- •b. MTX, if the dose is > 20 mg/week; or if there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1), or if there has been any change in route of administration.
- •c. Azathioprine (AZA), if the dose is > 150 mg/day and there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1) and any change in route of administration.
- •d. Leflunomide, if the dose is >20 mg/day; or if there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1).
- •e. Mycophenolate mofetil (MMF), if the dose is >2g/day; or if there is any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1).
- •f. Any other DMARD, immunosuppressant, or antiproliferative agent.
- •g. Any medication that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of subject safety or study results.
- •h. Any increase or initiation of new doses of cevimeline or pilocarpine and cyclosporine eye drops (Restasis®) within 2 weeks prior to signing the ICF through randomization (Day 1).
- •Exclusion criteria for Population 2:
- •1.Use of the following medications:
- •a. Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) if they have been initiated or if the dose has changed within 8 weeks prior to signing the ICF or during the screening period.
- •b. Oral, intramuscular, IV, or intraarticular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1).
- •c. MTX, AZA, leflunomide, other cDMARD, or immunosuppressive or antiproliferative medications.
- •d. Any medication that in the opinion of the investigator would interfere with evaluation of the IP or interpretation of subject safety or study results
- •e. Any increase or initiation of a new dose of regularly scheduled nonsteroidal anti-inflammatory drugs within 2 weeks prior to signing the ICF through randomization (Day 1).
- •f. Any increase or initiation of new doses of cevimeline or pilocarpine and cyclosporine eye drops (Restasis) within 2 weeks prior to signing the ICF through randomization (Day 1).
- •Exclusion criteria common for both Population 1 & 2:
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