EUCTR2021-001567-25-ES进行中（未招募）1 期
Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- 性别
- All
入选标准
- •- Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria
- •- Positive ANA (titer =1:80) during screening
- •- Positivity for at least one serological characteristic
- •- Total hSELENA-SLEDAI score =6 (including points attributed from arthritis and rash) during screening and at randomization as confirmed by a Sponsor-selected independent reviewer(s)
- •- At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
- •- Receiving at least one of the SOC for SLE (combination is possible)
- •- Body weight within 45 kg to 120 kg (inclusive) at screening
- •- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
- •- Active and severe lupus nephritis
- •- Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
- •- Known or suspected drug-induced lupus
- •- History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment
- •- History or current hypogammaglobulinemia
- •- Serious systemic viral, bacterial or fungal infection
- •- Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution
- •- Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest X rays) and examination, and tuberculosis testing
- •- High dose of steroids, or a change in dose within 4 weeks prior to randomization
- •- High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
- •- High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
- •- Use of cyclophosphamide within 3 months prior to screening
- •- Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
- •- Participants likely to require multiple courses of OCS during the study for chronic diseases other than SLE
- •- Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
- •- Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization.
研究者
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