NCT07470957尚未招募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 (ELOWEN-1)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 202
- 试验地点
- 1
- 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
研究概览
简要总结
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:
Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.
Intervention Form: Film-coated tablet.
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
- Triple (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
- •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 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 2019 classification criteria.
- •Participants with disease duration (cutaneous disease and, where applicable, SLE) of >= 6 months from time of diagnosis to Screening.
- •Participants with CLASI-A score >= 8 at Screening and Day 1 visits.
- •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
Enpatoran
Experimental
干预措施: Enpatoran (Drug)
Enpatoran
Experimental
干预措施: Standard of care (SoC) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Standard of care (SoC) (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
时间窗: 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)(From Day 1 to Week 24)
- Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters(From Day 1 to Week 24)
- Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline(At Weeks 4 and 24)
- Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24(At Week 24)
- Percentage of Participants With BICLA Response and Clinically Meaningful Corticosteroid (CS) Reduction(Day 1 up to Week 12 and thereafter upto Week 24)
- Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24(Baseline and at Week 24)
- Change from Baseline in CLASI-A Erythema at Week 24(Baseline and at Week 24)
- Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24(Baseline and at Week 24)
- Change from Baseline in CLASI-A Alopecia at Week 24(Baseline and at Week 24)
- Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24(At Week 24)
- Percentage of Participants with BILAG Moderate to Severe Flares(up to Week 24)
- Time to First Moderate/Severe BILAG Flare(Day 1 up to 24 weeks)
- Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose(Day 1 up to 24 weeks)
研究者
研究点 (1)
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