EUCTR2017-005026-37-GR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 821
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
- •Type of Patient and Disease Characteristics
- •[1] Are at least 18 years of age.
- •[2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
- •[3] Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al. 1982; Hochberg et al. 1997) prior to randomization.
- •[4] Have 1 or more of the following as assessed by the central lab during
- •screening: a positive antinuclear antibody (ANA; titer =1:80), and/or a positive antidsDNA,
- •and/or a positive anti-Smith (anti-Sm). Patients with an ANA <1:80 at
- •screening with documentation of a historical ANA =1:80 may be eligible, as
- •assessed by the eligibility review committee.
- •Note: The ANA, anti-dsDNA, and anti-Smith measurements may be Repeated by the central lab once during the screening period, and the value resulting from repeat testing may be accepted for enrollment eligibility if it meets the eligibility criterion.
- •[5] Have a total SLEDAI-2K score =6 during screening, with at least 4 points attributed to clinical items (not including items requiring laboratory value assessment). SLEDAI-2K items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period.
- •[6] Have a clinical SLEDAI-2K score =4 at Baseline (Visit 2); not including any items requiring laboratory value assessment.
- •[7] Have at least 1 BILAG A score or 2 BILAG B scores during the screening period.
- •BILAG items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period.
- •Prior/Concomitant Therapy
- •[8 ]Are receiving at least one of the following SoC medications for SLE:
- •a. A single antimalarial (such as hydroxychloroquine, chloroquine, quinacrine)
- •At a stable therapeutic dose for at least 8 weeks prior to screening (Visit 1).
- •b. A single immunosuppressant (such as methotrexate [MTX], azathioprine,
- •mycophenolate, tacrolimus) at a stable therapeutic dose for at least 8 weeks
- •prior to screening (Visit 1).
- •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 734
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
排除标准
- •-Have severe active lupus nephritis defined clinically and/or by histologic evidence of proliferative glomerulonephritis on renal biopsy (if available) within the 24 weeks prior to screening, or urine protein/creatinine ratio >200 mg/mmol (as an estimate of approximate proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease [MDRD]) <40 mL/min/1.73 m2 at screening, or as determined by the eligibility review committee.
- •-Have active CNS lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by SLEDAI-2K
- •-Have active fibromyalgia that, in the investigator’s opinion, would make it
- •difficult to appropriately assess SLE activity for the purposes of this study.
- •-Have been treated for or had an active occurrence of a systemic inflammatory condition other than SLE such as, but not limited to, RA, juvenile chronic
- •arthritis, spondyloarthropathy, Crohn’s disease, ulcerative colitis, or psoriatic arthritis within the 12 weeks prior to screening. Patients with secondary
- •Sjögren’s syndrome are not excluded.
- •-Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study
- •-Have screening ECG abnormalities
- •-Have experienced any of the following within 12 weeks of screening: VTE, MI, unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- •- Have a history of: recurrent (= 2) VTE (DVT/PE); cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly (other than primarily due to SLE); have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to randomization.
- •- Have a current or recent (<4 weeks prior to randomization) clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection that in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.
- •- Have symptomatic herpes simplex at the time of randomization.
- •- Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
- •- Have a history of disseminated/complicated herpes zoster
- •- Have a positive test for HBV, hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV
- •ribonucleic acid [RNA]-positive).
- •- Have evidence of HIV infection and/or positive HIV antibodies.
- •- Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
- •- Have evidence of active TB or latent TB
- •- Have received parenteral corticosteroids within 6 weeks of screening (Visit 1), or are expected to require parenteral corticosteroids during the study.
- •- Have received any of the following medications:
- •a. Biologic treatments for immunologic disease within 4 weeks of screening.
- •b. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-IFN therapy) within 12 weeks of screening.
- •c. Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg) within 24 weeks of screening.
- •- Have received a JAK inhibitor or TYK-2 inhibitor
- •- Have been treated with probenecid that cannot be discontinued for the duration of the study.
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