EUCTR2016-003558-34-ES进行中（未招募）1 期
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Male or female 18 to 75 years of age (inclusive) at the time of signing initial consent, with all of the following at Screening: a. Diagnosis of SjS based on AECG classification, b. Active SjS, with ESSDAI =5 c. Seropositivity for anti-SSA or anti-SSB, per central laboratory as described in the protocol
- •2) A negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 are required for female subjects of child-bearing potential
- •3) Starting at the time of written consent, through the study, and for 90 days (male) and 36 days (female) following their last dose of study drug: a. Male and female subjects of childbearing potential who engage in heterosexual
- •intercourse must agree to use protocol specified method(s) of contraception, b. Male subjects must agree to refrain from sperm donation c. Female subjects must agree not to breastfeed or to donate/harvest eggs for the purpose of fertilization,
- •4) Subjects with prior exposure to a B-cell depleting bDMARD (at any time) must have a documented return of CD19+ B cells at Screening.
- •5) Stable dose (defined as no change in prescription for at least 4 weeks prior to Day 1) of NSAIDs, HCQ, MTX and/or oral corticosteroids is permitted during the study, but not required (see protocol for definitions and permitted doses).
- •6) Meet tuberculosis (TB) Screening criteria as defined in the protocol
- •7) Are willing and able to sign the informed consent form and comply with study requirements, procedures, and scheduled visits.
- •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 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1) Concurrent treatment at Screening with any bDMARD
- •2) Any prior use of cyclophosphamide
- •3) Use of cyclosporine within 4 weeks prior to the first dose of study drug (Day 1) or anticipated chronic use while on study
- •4) Clinically significant abnormalities on 12-lead ECG as judged by the investigator.
- •5) Treatment with moderate or strong CYP3A inducers or inhibitors or strong P-gp inducers within 2 weeks prior to the first dose of study drug (Day 1) or anticipated chronic use while on study
- •6) Participation in any clinical study of an investigational drug within 4 weeks or 5 drug half-lives prior to Screening, whichever is longer. Washout duration for exposure to investigational biologics should be discussed with the sponsor
- •7) Treatment with any commercially available or investigational drug listed as listed in the protocol within 3 months of Screening
- •8) History of opportunistic infection or immunodeficiency syndrome which would put the subject at risk, as per investigator judgment
- •9) History of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or history of disseminated/complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, CNS involvement or postherpetic neuralgia) at any time
- •10) Known hypersensitivity to the study drug, its metabolites, or any of the excipients, or previous clinically significant allergic reaction to any drug, per judgment of the investigator
- •11) Another highly active inflammatory/autoimmune/rheumatic disease (such as highly active RA, highly active SLE, highly active nephritis or CNS inflammation) which would compromise subject safety or interfere with the conduct of the study.
- •12) History of head/neck irradiation, sarcoidosis, graft v host disease, or IgG4 related disease
- •13) Female subjects who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study up to 36 days after the last dose of study drug or males who are planning to father a child during the study up to 90 days after the last dose of study drug
- •14) Major surgery (requiring regional block or general anesthesia) within 30 days prior to Screening, or planned during the study
- •15) History of live or attenuated vaccines within 60 days of Day 1, or planned during the study period or for 12 weeks after the subject's last dose of study drug.
- •16) History of lymphoma or any malignancy of any organ system, save for basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ, which has been successfully treated with no sign of recurrence for at least 5 years prior to Screening
- •17) Positive serology for human immunodeficiency virus (HIV) 1 or 2 at Screening,
- •18) Hepatitis B virus (HBV) surface antigen (HBsAg) or positive HBV core antibodies at Screening
- •19) Hepatitis C virus (HCV) antibodies and positive HCV RNA viral load (VL).
- •20) Serious active infection of any kind at Screening or Day 1
- •21) Blood loss (> 500 mL) or blood product transfusion within 12 weeks of Day 1
- •22) Known bleeding disorder or hypercoagulable state; antiphospholipid antibody syndrome with prior clinically significant event (
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