A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 379
- 试验地点
- 238
- 主要终点
- Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
研究概览
简要总结
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
- •Have a Body Mass Index (BMI) within the less than or equal to (<=) 40 kilograms per meter square (inclusive) at Screening
- •Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part
- •In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participants who experienced serious event(s) related to the study intervention during the WILLOW study
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
- •Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 [(SARS-CoV-2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
- •Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
- •Participation in any other investigational drug study after the WILLOW study Week 24
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
M5049 low dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.
干预措施: M5049 low dose (Drug)
M5049 medium dose+ Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.
干预措施: M5049 medium dose (Drug)
M5049 high dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .
干预措施: M5049 high dose (Drug)
M5049 low dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received low dose of M5049 in WILLOW study will continue to receive M5049 low dose and matching placebo.
干预措施: Placebo (Drug)
M5049 medium dose+ Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received medium dose of M5049 in WILLOW study will continue to receive M5049 medium dose and matching placebo.
干预措施: Placebo (Drug)
M5049 high dose + Placebo
Participants with CLE (active SCLE and/or DLE) or SLE who received M5049 matched placebo or high dose of M5049 in WILLOW study will receive M5049 high dose .
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
时间窗: Baseline up to Week 50 (Long Term Extension Part 1)
Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs)
时间窗: Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2))
次要结局
- Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected(Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2))