NCT04753697已完成3 期
A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis
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
- 430
- 试验地点
- 212
- 主要终点
- Change From Baseline in Mean Dysphagia Days (DD) at Week 24
研究概览
简要总结
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.
Participants will be randomized at the beginning of the study into 3 treatment arms:
- Placebo for Induction and Maintenance
- CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
- CC-93538 360 mg SC once weekly for Induction and Maintenance
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
- •Participants must satisfy the following criteria to be enrolled in the study:
- •Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg.
- •Histologic evidence of eosinophilic esophagitis, defined as a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus.
- •3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.
- •Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study.
- •Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study.
- •Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study.
- •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
- •The presence of any of the following will exclude a participant from enrollment:
- •Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
- •Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance.
- •Evidence of a severe endoscopic structural abnormality in the esophagus.
- •Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study.
- •Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.
- •Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.
- •Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.
- •Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study.
- •Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.
- •Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.
- •Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.
- •Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis).
- •Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus.
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.
- •Females who are pregnant or lactating.
研究组 & 干预措施
Administration of CC-93538
Experimental
CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks
干预措施: CC-93538 (Drug)
Administration of CC-93538 and Placebo
Experimental
CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks.
During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.
干预措施: CC-93538 (Drug)
Administration of CC-93538 and Placebo
Experimental
CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks.
During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.
干预措施: Placebo (Other)
Administration of Placebo
Placebo Comparator
Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Mean Dysphagia Days (DD) at Week 24
时间窗: Baseline (Day 1) and Week 24
Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24
时间窗: Week 24
Blood samples were collected to assess esophageal eosinophil count.
次要结局
- Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48(Week 48)
- Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24(Week 24)
- Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48(Week 48)
- Change From Baseline in Mean Dysphagia Days (DD) at Week 48(Baseline (Day 1) and Week 48)
- Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24(Baseline (Day 1) , Week 24)
- Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48(Baseline (Day 1) , Week 48)
- Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24(Baseline (Day 1), Week 24)
- Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48(Baseline (Day 1) , Week 48)
- Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24(Baseline (Day 1), Week 24)
- Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48(Baseline (Day 1) , Week 48)
- Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24(Baseline (11 days prior to Day 1) and Week 24)
- Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48(Baseline (Day 1) , Week 48)
- Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24(Baseline (11 days prior to Day 1) and Week 24)
- Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48(Baseline (11 days prior to Day 1) and Week 48)
- Change From Baseline in Mean Dysphagia Days (DD) Through Week 24(Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24(Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Time to First Event of Eosinophilic Esophagitis (EoE) Flare(From first dose (Day 1) and Up to Week 48)
- Time to First Use of Rescue Medication(From first dose (Day 1) and Up to Week 48)
- Percentage of Participants With Any Events of Use of Rescue Medication(From first dose (Day 1) and up to Week 48)
- Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare(From first dose (Day 1) and up to Week 48)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From first dose (Day 1) till up to Week 48)
- Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift(From first dose (Day 1) till up to Week 48)
- Number of Participants With Post-Baseline Vital Sign Abnormalities(From first dose (Day 1) till up to Week 48)
- Change From Baseline in Physical Parameters - Height at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Physical Parameters - Height at Week 48(Baseline (Day 1) and Week 48)
- Change From Baseline in Physical Parameters - Weight at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Physical Parameters - Weight at Week 48(Baseline (Day 1) and Week 48)
- Change From Baseline in Physical Parameters - Body Mass Index at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Physical Parameters - Body Mass Index at Week 48(Baseline (Day 1) and Week 48)
- Number of Participants With Anti-Drug Antibodies (ADA)(Pre-dose Week 24 and Pre-dose Week 48)
- Serum Trough Concentration of CC-93538 at Week 24 and Week 48(Pre-dose Week 24 and Pre-dose Week 48)
研究者
研究点 (212)
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