EUCTR2020-004336-16-IT进行中（未招募）1 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 -
CELGENE INTERNATIONAL II SàR0 个研究点目标入组 399 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 399
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients aged = 12 and = 75 years, with a body weight of > 40 kg.
- •Histologic evidence of EoE, defined as a peak count of = 15 eos/HPF at 2 levels of the esophagus.
- •Subject-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 PPI (8 weeks). Subjects on a PPI 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.
- •Subjects 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.
- •Subjects must agree to maintain a stable diet (including any food elimination for the treatment of food allergy or EoE) and not introduce any changes in their diet from the first Screening Visit to the end of the study.
- •FCBP 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 366
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
- •Other GI disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with EoE, liver function impairment; or a known HFI.
- •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). SC 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, cardiovascular condition, neurologic disorder, or psychiatric illness that compromises the subject's ability to accurately document symptoms of EoE).
- •Active or ongoing infections including parasitic/helminthic, hepatitis, TB, or AIDS.
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.
- •Females who are pregnant or lactating.
研究者
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