A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallelgroup 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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline. Response on SRI-4 is defined as
研究概览
简要总结
The goal of this clinicaltrial is to see how well cenerimod reduces symptoms of Systemic LupusErythematosus in adult patients with moderate to severe symptoms.
The main questionsit aims to answer are:
• How well cenerimod workson top of the treatment already being administered.
• How safe cenerimod is foradult patients with Systemic Lupus Erythematosus.
Researchers will compare onedose of cenerimod and a placebo to see how well cenerimod works whenit is added to the treatment already being administered.
In this research study approximately 210 participantswill receive cenerimod and approximately 210 participants will receive placebofor 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism or American College of Rheumatology Criteria.
- •2.A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score greater than or equal to 6 and clinical mSLEDAI-2K score greater than or equal to
- •3.British Isles Lupus Assessment Group-2004 (BILAG) Grade B in at least 2 organ systems or a BILAG Grade A in at least 1 organ system.
排除标准
- •1.Pregnant, planning to be become pregnant up to Final Study Visit or lactating woman
- •Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE.
- •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.
结局指标
主要结局
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline. Response on SRI-4 is defined as
时间窗: At Month 12 compared to Day 1
• Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index 2000 score (mSLEDAI-2K [SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K]), and
时间窗: At Month 12 compared to Day 1
• No new British Isles Lupus Assessment Group 2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and
时间窗: At Month 12 compared to Day 1
• No worsening from baseline in subjects’ lupus disease activity, where worsening is defined as an increase greater than or equal to 0.30 points on a 3 point Physician’s Global Assessment visual analog scale (PGA VAS), and
时间窗: At Month 12 compared to Day 1
• No violation of specified medication rules detailed in the core protocol.
时间窗: At Month 12 compared to Day 1
次要结局
- 1. Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline.(At Month 12 compared to Day 1)