NCT05214768已完成3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Subjects With Eosinophilic Gastroenteritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 48
- 试验地点
- 50
- 主要终点
- Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic evidence of eosinophilic gastroenteritis (EGE) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE
- •Has weekly symptom scores of ≥ 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1
- •Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit
- •Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose
排除标准
- •Ascites requiring treatment or symptomatic ascites
- •History of inflammatory bowel disease, achalasia or esophageal surgery
- •Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
CC-93538
Experimental
干预措施: CC-93538 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies
时间窗: Baseline and Week 16
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.
次要结局
- Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16(Baseline and Week 16)
- Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48(Baseline and Week 48)
- Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16(Week 16)
- Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48(Baseline and week 48)
- Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48(Baseline and Week 48)
- Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline(Baseline and Week 16)
- Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline(Baseline and Week 48)
- Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)(Week 16)
- Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)(Week 48)
- Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale(Week 16)
- Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale(Baseline and Week 48)
- Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years)(Baseline and Week 16)
- Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years)(Baseline and Week 16)
- Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years)(Baseline and Week 48)
- Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years)(Baseline and Week 48)
- Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy(Through Week 16)
- Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy(Through Week 48)
- Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use(From Week 16 through Week 48)
- Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero(Week 24, 32, 40 and 48)
- Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events(From Day 1 untill Week 48)
- Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements(From Day 1 untill Week 48)
- Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters(From Day 1 untill Week 48)
- Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters(From Day 1 untill Week 48)
- Induction and Maintenance: Number of Participants With Anti-Drug-Antibody(From Day 1 till Week 48)
- Induction Phase: CC-93538 Trough Concentration at Week 16(Week 16)
- Maintenance Phase: CC-93538 Trough Concentration at Week 48(Week 48)
研究者
研究点 (50)
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