NCT07440537招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 27
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤75 years.
- •Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.
- •Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and/or subacute cutaneous lupus erythematosus (SCLE).
- •CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.
- •May have concomitant systemic lupus erythematosus (SLE) or not.
- •The treatment regimen is stable and can be maintained until the end of the study treatment.
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the first dose on Day
- •Women of childbearing potential (WOCBP) and male subjects must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose
排除标准
- •Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.
- •Patients with drug-induced cutaneous lupus erythematosus and/or drug-induced systemic lupus erythematosus.
- •Subjects with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as the primary disease.
- •5. Other autoimmune diseases except for secondary Sjögren's syndrome.
- •Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection.
- •7. Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb).
- •8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.
- •9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.
- •10. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.
研究者
研究点 (27)
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