2024-512767-30-00招募中2 期
CDX0159-08: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)
Celldex Therapeutics Inc.19 个研究点 分布在 4 个国家目标入组 23 人开始时间: 2024年7月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 19
- 主要终点
- Absolute change from baseline to Week 12 in the PMC/high power field (hpf)
研究概览
简要总结
To evaluate efficacy of barzolvolimab, compared to placebo, in reducing esophageal intraepithelial infiltration of mast cells as assessed by peak esophageal intraepithelial mast cell (PMC) count in EoE patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •1 - Read, understood, and provided written informed consent, after the nature of the study has been fully explained.
- •2 - Male or female, ≥ 18 years of age at the time of signing the informed consent
- •3 - Documented diagnosis of EoE by endoscopy consent
- •4 - Esophageal intraepithelial eosinophilic infiltration, with peak esophageal intraepithelial eosinophil count (PEC) of ≥ 15 per high power field (hpf) from at least 2 of 3 levels (proximal, mid, and distal) of the esophagus at the Screening/Baseline esophagogastroduodenoscopy (EGD) at the Screening Visit.
- •5 - Must be symptomatic, defined as: a. History (by patient report) of an average of at least 2 days per week with dysphagia with intake of solid foods during 1 month prior to the Screening Visit and b. At least 4 days with dysphagia (answer of "Yes" to DSQ Question #2) within the last 2 weeks immediately prior to randomization.
- •6 - Must have been on a stable diet which includes solid foods for at least 2 months prior to the Screening Visit and throughout the study. Note: Stable diet is defined as no initiation or elimination of single or multiple food groups or reintroduction of previously eliminated food groups.
- •7 - Have had inadequate response to or is inappropriate for and/or intolerant to a standard-of-care treatment for EoE (e.g., PPI, swallowed topical corticosteroids, or dietary elimination) based on the investigator's clinical judgment.
排除标准
- •1 - Diagnosis of hypereosinophilic syndrome or Churg-Strauss syndrome (or eosinophilic granulomatosis with polyangiitis).
- •10 - Diagnosis of idiopathic anaphylaxis or other severe allergic reactions that in the opinion of the investigator, could increase the patient's risk for systemic hypersensitivity reactions; or any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines.
- •11 - Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting study treatment.
- •2 - History of a clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis.
- •3 - Known active Helicobacter pylori infection
- •4 - History of coagulation disorders or esophageal varices
- •5 - History of achalasia, Crohn's disease, ulcerative colitis or celiac disease
- •6 - Esophageal dilation within 3 months prior to the Screening Visit or a planned/elective esophageal dilation anytime during the study.
- •7 - Avoiding solid foods or using feeding tube
- •8 - Non-biologic systemic (oral or injectable) agents within 4 weeks or 5 half-lives, whichever is longer, prior to the Screening Visit.
- •9 - Biologic therapy within 5 half-lives (or detectable serum level), prior to the Screening Visit. Note: Biologic agents include but are not limited to interleukin (IL)-4 receptor inhibitor (dupilumab), IL-5 inhibitors (e.g., mepolizumab, benralizumab), IL-13 inhibitors (e.g., tralokinumab, lebrikizumab), antiIgE (e.g., omalizumab), IFN-γ inhibitors, or other approved or investigational biologics.
结局指标
主要结局
Absolute change from baseline to Week 12 in the PMC/high power field (hpf)
Absolute change from baseline to Week 12 in the PMC/high power field (hpf)
次要结局
- 1 - Absolute changes from baseline to Week 12 in DSQ
- 2 - Absolute change from baseline to Week 12 in PMC/hpf among patients with baseline PMC ≥ 12/hpf
- 3 - Absolute change from baseline to Week 12 in PEC/hpf
- 4 - Percent (%) change from baseline to week 12 in PMC/hpf
- 5 - Incidence of TEAEs
研究者
Science Department
Scientific
Celldex Therapeutics Inc.
研究点 (19)
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