PER-050-16尚未招募未知
A Phase 2b, Multidose, Multicenter, Double-blind, Placebocontrolled, 24 Week Study to Evaluate the Efficacy and Safety of Intravenous Infusion with Recombinant Human Soluble Fc-gamma IIB Receptor SM101 in Subjects with Systemic Lupus Erythematosus (SLE)
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
- 性别
- All
入选标准
- •1.Male or female adult subjects 18-70 years of age at the time of Screening, who provide written informed consent prior to any study-related procedure.
- •2.Diagnosis of SLE by fulfilling at least 4 criteria of the ACR 1982 revised classification criteria and/or SLICC classification criteria for SLE during the course of their illness confirmed at the Screening visit.
- •3.Moderate to severe active SLE disease as defined by:
- •SLEDAI-2K score ≥ 6 and Clinical SLEDAI-2K score ≥ 4 at Screening AND
- •BILAG 2004 organ domain scores of ≥ 1A or ≥ 2B at Screening AND
- •Clinical SLEDAI-2K score ≥ 2 at Baseline (Day 1)
- •4.Positive test results for antinuclear antibodies (ANA) (human epithelial cell [Hep]-2 ANA ≥ 1:80) and at least 1 of the following (as confirmed by a central laboratory) at Screening:
- •dsDNA antibody OR
- •low complement C3 OR
- •positive Ro, La, ribonucleic protein (RNP), or Smith autoantibodies
- •5.If female of childbearing potential, subject presents with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agrees to employ adequate birth control measures for the duration of the study.
- •6.Subject is willing and able to comply with the requirements of the protocol.
排除标准
- •1. Use of immunosuppressant or antimalarial drugs inconsistent with the following allowance:
- •subjects are permitted to use only 1 of the immunosuppressive oral therapies at the allowed doses as in addition to an antimalarial (eg, hydroxychloroquine up to 400 mg/day OR chloroquine up to 250 mg/day):
- •≤ 2 mg/kg/day AZA
- •≤ 3 g/day MMF [or equivalent], or
- •≤ 25 mg/week MTX
- •Doses of permitted immunosuppressant and/or antimalarial, if being used, must have been stable for 8 weeks prior to Screening with plan to remain stable during the study.
- •2. Subject has received the following immunosuppressive or immunomodulating treatments prior to Screening visit:
- •Rituximab or ocrelizumab within 48 weeks
- •Immunoglobulins (eg, intravenous immunoglobulin [IVIG]) within 16 weeks
- •Belimumab within 12 weeks
- •Tumor necrosis factor-alpha (TNF-) inhibitors within 12 weeks (including investigational biosimilars)
- •Plasmapheresis within 12 weeks
- •Cyclophosphamide and chlorambucil within 12 weeks
- •Abatacept within 8 weeks
- •Cyclosporine, tacrolimus, and any other immunosuppressant or immunomodulating drug not listed above or in exclusion criterion 1 within 8 weeks
- •3. Other investigational treatments within the last 3 months or 5 terminal half-lives, whichever is longest, prior to the Screening visit
- •4. Subjects changing or introducing oral corticosteroids > 20 mg/day within 4 weeks of the Screening visit (IV, IM, and IA corticosteroids are not permitted within 4 weeks of Screening, during Screening, or during the treatment period)
- •5. Active central nervous system SLE which, in the opinion of the Investigator or Sponsor, is
- •uncontrolled within 3 months of the Screening visit and/or leading to the incapacity of the subject to comply with consent and protocol requirements
- •6. Secondary antiphospholipid antibody syndrome associated with a thromboembolic event in the 12 months prior to or during Screening and/or associated with evidence of unstable or inadequate anticoagulation during Screening
- •7. Presence of other systemic rheumatic disease other than and not related to SLE (secondary Sjogren´s syndrome due to SLE is permitted)
- •8. Baseline chronic comorbidities (other than SLE) requiring systemic corticosteroid therapy within 6 months prior to the Screening visit, during Screening, and during the course of the study.
- •9. History of or positive HIV, hepatitis C antibody (unless polymerase chain reaction negative), HBsAg (+), and/or hepatitis B core total antibody (+) (HBV DNA negative which may be done if Hep B core IgG Ab positive and HBsAg negative) at Screening
- •10. History of incompletely treated or current diagnosis of active TB, or latent TB infection (LTBI), determined by a TB skin test with purified protein derivative as evidenced by induration ≥ 5 mm or a positive Quantiferon centrally or positive or borderline T-SPOT (Elispot) test performed locally, either at Screening or documented with results within 3 months of the Screening visit. Subjects who have previously completed appropriate and documented LTBI treatment will not be required to be tested
- •Subjects with current household contacts with active TB will also be excluded unless treated and evidence of household contacts being treated
- •Indeterminate Quantiferon or borderline T-SPOT tests may be repeated once, and will be considered positive if retest results ar
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