EUCTR2016-001586-87-GB进行中（未招募）1 期
A Phase 2, Double Blind, Placebo Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome - RSLV-132 in Primary 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
- 28
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
- •Subjects who meet all of the following criteria at Screening may be included in the study:
- •1. Meet 4 of the 6 criteria (must include histopathology or autoantibodies) of the 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren’s Syndrome
- •2. Elevated levels of anti Ro-52 or anti Ro-60 antibodies (within laboratory positive range);
- •3. Positive interferon signature (whole blood cell interferon signature metric >1);
- •4. Stable medications used to treat Sjogren’s syndrome for the 30 days prior to the Baseline visit;
- •5. Able to communicate and able to provide valid, written informed consent;
- •6. Ages 18 to 85 inclusive;
- •7. Minimum weight of 45 kg;
- •8. Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels > 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD], an intrauterine hormone releasing system [IUS] a male sexual partner who agrees to use a male condom with spermicide; a sterile or vasectomized sexual partner) for at least 2 months prior to dosing and until 90 days following the End of Study. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test [ß-hCG] at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 90 days after the last dose.
- •9. Male participants, who are not sterile or vasectomized, must agree to use a male condom with spermicide from the first dose until 90 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 90 days after the last dose.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Any of the following will exclude potential subjects from the study:
- •1. Previously diagnosed with systemic lupus, systemic sclerosis, or inflammatory myopathy
- •2. Use of hydroxychloroquine within 30 days of Baseline;
- •3. Use of cyclophosphamide within 180 days of Baseline;
- •4. use of belimumab, abatacept, or TNF inhibitors wit Uin 90 days of Baseline;
- •5. Use of rituximab within 6 months of Baseline (documentation of B-cell counts within the normal range for the reference laboratory is required for subjects within 1 year of rituximab usage)
- •6. Use of oral corticosteroids equivalent to prednisone dose of >10 mg/day within 30 days of Baseline;
- •7. Past head and neck radiation;
- •8. Current untreated lymphoma at Baseline;
- •9. Known IgG4-related disease
- •10. Graft versus host disease
- •11. The presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
- •12. Positive test for hepatitis B, C, or HIV at Screening;
- •13. Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
- •14. Positive pregnancy test at Screening or Baseline;
- •15. Female subjects currently breast feeding at Baseline;
- •16. Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.
研究者
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