NCT04781816已完成2 期
Randomized, Double-blind, Placebo Controlled, Proof of Concept Study Assessing the Efficacy and Safety of the RIPK1-inhibitor SAR443122 in Patients With Moderate to Severe Subacute or Discoid/Chronic Cutaneous Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 78
- 试验地点
- 50
- 主要终点
- Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12
研究概览
简要总结
Primary Objective:
- Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)
Secondary Objectives:
- Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)
- Assess the effect of SAR443122 on CLE induced itch and overall pain
- Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo
- Assess the effect of SAR443122 on the CLASI components score
- Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE)
- Assess oral cavities for patients with oral lesions
- Assess the disease specific quality of life (QoL)
- Assess the safety and tolerability of SAR443122 in patients with CLE
- Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
详细描述
Total study duration per participant was up 20 weeks including:
- A screening period of up to 4 weeks
- A treatment period of 12 weeks
- A post treatment follow-up period of 4 weeks
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR443122
Experimental
SAR443122 for 12 weeks
干预措施: SAR443122 (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12
时间窗: Baseline (Day 1) and Week 12
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
次要结局
- Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12(Week 12)
- Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12(Baseline (Day 1) and Week 12)
- Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12(Baseline (Day 1) and Week 12)
- Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12(Week 12)
- Change From Baseline in CLASI Components' Score Over Time(Baseline (Day 1) and Weeks 4, 8, 12, and 16)
- Number of Participants With PCSA in Urinalysis(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12(Week 12)
- Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline(Baseline (Day 1) and Week 12)
- Change From Baseline in SKINDEX-29+3 Total Score at Week 12(Baseline (Day 1) and Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Number of Participants With PCSA in Clinical Chemistry(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Number of Participants With PCSA in Electrocardiogram (ECG)(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Number of Participants With PCSA in Vital Signs(From first dose of study treatment (Day 1) up to end of study (Week 16))
- Maximum Plasma Concentration (Cmax) of SAR443122(2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57)
- Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122(2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57)
- Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122(2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57)
- Terminal Elimination Half-Life (t1/2z) of SAR443122(1 hour before morning dose and 2-5 hours post first morning dose on Day 85)
研究者
研究点 (50)
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