2025-523871-44-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 41
- 主要终点
- Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >=70 Percent (%) Decrease in CLASI-A Score From Baseline at Week 24
研究概览
简要总结
To demonstrate the efficacy of enpatoran in reducing cutaneous disease activity by achieving at least 70% reduction from Baseline in CLASI-A total score (CLASI-70) at Week 24
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Min. Age: 18 Years Max. Age: 75 Years
- •Vaccinations are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- •Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).
- •Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.
- •Participants with diagnosis of SLE and fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.
- •For participants with SLE: -Participants with diagnosis of SLE and fulfill EULAR/ACR 2019classification criteria.
- •For participants with SLE: -Participants with disease duration (cutaneous disease and, where applicable, SLE) of >= 6 months from time of diagnosis to Screening.
- •For participants with SLE: - Participants with CLASI-A score >= 8 at Screening and Day 1 visits.
- •For participants with SLE: - Other protocol-defined inclusion criteria may apply.
排除标准
- •Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.
- •Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator’s or Sponsor/designee’s opinion constitutes inappropriate risk or contraindication for participation.
- •Participants with drug-induced lupus (SLE or CLE).
- •Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate, azathioprine or an oral calcineurin inhibitor is allowed).
- •Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
- •Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Placebo to match Enpatoran
Placebo
干预措施: Placebo to match Enpatoran (Drug)
Enpatoran
Test
干预措施: Enpatoran (Drug)
结局指标
主要结局
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >=70 Percent (%) Decrease in CLASI-A Score From Baseline at Week 24
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >=70 Percent (%) Decrease in CLASI-A Score From Baseline at Week 24
次要结局
- Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 24.
- Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [ Time Frame: From Day 1 to Week 24 ].
- Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [ Time Frame: From Day 1 to Week 24 ].
- Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24.
- Percentage of Participants WithCLASI-50 Response, Defined as>=50% Decrease in CLASI-A Score From Baseline at Weeks 4 and 24.
- Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [ Time Frame: Day 1 up to Week 12 and thereafter upto Week 24 ].
研究者
Global Regulatory Affairs
Scientific
Merck Healthcare KGaA
研究点 (41)
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