PER-011-23招募中3 期
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of Cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 8
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
- •Inclusion criteria at screening:
- •-Signed Informed Consent Form (ICF) prior to any study-mandated procedure.
- •-Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
- •- An modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score = 6 and clinical mSLEDAI-2K score = 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include leukopenia.
- •- British Isles Lupus Assessment Group-2004 (BILAG) Grade B in = 2 organ systems or a BILAG Grade A in = 1 organ system.
- •Physician's Global Assessment (PGA) score = 1.0 on a 0 to 3 Visual Analogue Scale (VAS).
- •Currently treated with one or more of the following SLE background medications:
- •oAnti-malarials (= 400 mg/day hydroxychloroquine, = 500 mg/day chloroquine, = 100 mg/day quinacrine).
- •oMycophenolate mofetil (= 2 g/day) / mycophenolic acid (=1.44 g/day).
- •oAzathioprine (= 2 mg/kg/day).
- •oMethotrexate (= 25 mg/week).
- •oOral Corticosteroids (OCS):
- •?if OCS is the only SLE background medication: = 7.5 mg/day and =30 mg/day prednisone or equivalent.
- •?if OCS is not the only SLE background medication: = 30 mg/day prednisone or equivalent.
- •oBelimumab (=10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously (s.c.).
- •Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening.
- •For women of childbearing potential (WoCBP):
- •oNegative serum pregnancy test at Screening.
- •oAgreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
- •oAgreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.
- •Inclusion criteria at randomization:
- •A clinical mSLEDAI-2K score = 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
- •British Isles Lupus Assessment Group-2004 (BILAG) Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.
- •Physician's Global Assessment (PGA) score = 1.0 on a 0 to 3 visual analog scale.
- •Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory):
- •oAnti-dsDNA antibodies elevated to above normal,
- •oComplement C3 < lower limit of normal,
- •oAntinuclear Antibodies with a titer of at least 1:160,
- •oAnti-Smith antibody elevated to above normal,
- •oPlatelets < 200 000/µL,
- •oUrine protein/creatinine ratio > 12.5 mg/mmol (110.5 mg/g).
- •Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization):
- •oAntimalarials (= 400 mg/day hydroxychloroquine, = 500 mg/day chloroquine, = 100 mg/day quinacrine);
- •oMycophenolate mofetil (= 2 g/day) / mycophenolic acid (= 1.44g/day);
- •oAzathioprine (= 2 mg/kg/day)
排除标准
- •Main Exclusion Criteria:
- •Pregnant, planning to be become pregnant up to Final Study Visit or lactating women.
- •Severe central nervous system lupus or active severe or unstable neuropsychiatric SLE characterized by: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:
- •oThat would make the subject unable to fully understand the ICF; OR
- •oWhere, in the opinion of the Principal Investigator, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
- •A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.
- •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 6 months prior to Screening.
- •Resting Heart Rate < 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.
- •An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of > 470 ms (females) / > 450 ms (males) at Screening or at Randomization.
- •History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
- •History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.
- •History or presence of malignancy (except for surgically excised basal or squamous cell skin or mucosal lesions, including dysplasia and carcinoma in situ), lymphoproliferative disease, or history of total lymphoid irradiation.
- •Presence of macular edema or active uveitis detected by optical coherence tomography (OCT) during screening.
- •History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase > 3 × Upper Limit of Normal (ULN) or total bilirubin > 1.5 ULN (unless in the context of known Gilbert's Syndrome).
- •Significant hematology abnormality at screening assessment:
- •olymphocyte count < 500 /µL (0.5 × 10^9/L);
- •ohemoglobin < 7 g/dL;
- •owhite blood cell count < 2000/µL (2.0 × 10^9/L); or
- •oplatelets < 25000/µL (25 × 10^9/L) at screening assessment.
- •Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:
- •oß-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other an
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