EUCTR2018-001808-11-ES进行中（未招募）1 期
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •- Signed ICF prior to any study-mandated procedure
- •- Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria
- •- A mSLEDAI-2K score = 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not take into account leukopenia”
- •- Currently treated with stable doses of one or more of the following background medications:
- •Anti-malarials (= 400 mg/day hydroxychloroquine, = 500 mg/day chloroquine, = 100 mg/day quinacrine)
- •Mycophenolate mofetil (= 2 g/day)
- •Azathioprine (= 2 mg/kg/day)
- •Methotrexate (= 20 mg/week)
- •Corticosteroids (= 40 mg/day prednisone or equivalent)
- •Belimumab (=10 mg/kg every 4 weeks)
- •- History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre =1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre =30 IU/mL
- •- Women of childbearing potential (WOCBP):
- •Must have a negative serum pregnancy test at Screening
- •Must agree to undertake monthly urine pregnancy tests during the study
- •Must use highly effective methods of contraception from the screening visit until 4 months after taking the last dose of study treatment
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis.
- •- CNS lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment.
- •- A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis.
- •- History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
- •- Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within six months prior to Screening.
- •- An elevated QT corrected for HR on the basis of Fridericia’s formula interval of > 470 ms (females) / > 450 ms (males).
- •- History or presence of severe respiratory disease or pulmonary fibrosis.
- •- Active or latent tuberculosis .
- •- Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection.
- •- Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing.
- •- Presence of macular edema or active uveitis.
- •- Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy.
- •- Significant hematology abnormality: Lymphocyte count < 800 /µL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC count < 2500/µL (2.5 × 10e9/L) or platelets < 75000/µL (75 × 10e9/L).
- •- Estimated glomerular filtration rate < 60 mL/min/1.73 m2.
- •- Known allergy to S1P receptor modulators or any of the cenerimod formulation excipients
研究者
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