NCT05774184已完成2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 85
- 主要终点
- Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
详细描述
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Documented diagnosis of eosinophilic esophagitis (EoE) by endoscopy
- •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
- •Symptomatic, defined as • Average of ≥ 2 days per week with dysphagia with solid food intake in the 1 month prior to Screening, and • ≥ 4 days with dysphagia within the last 2 weeks prior to randomization
- •On a stable diet which includes solid foods for ≥ 2 months prior to Screening (and throughout the study)
- •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)
- •Willing to be compliant with completion of daily questionnaire
排除标准
- •Diagnosed with hypereosinophilic syndrome or Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis)
- •History of clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis
- •Known active Helicobacter pylori infection
- •History of coagulation disorders, esophageal varices, achalasia, Crohn's disease, ulcerative colitis, or celiac disease
- •Esophageal dilation within 3 months prior to Screening
- •Prior esophageal or gastric surgery that would confound the assessments of EoE
- •Esophageal stricture that is difficult to pass with a standard adult upper endoscope (9 to 10 mm) or stricture that requires dilation at the Screening EGD
- •Avoiding solid foods or using a feeding tube
- •Regular use of antiplatelet and/or anticoagulant therapy
- •Non-biologic systemic agents within 2 months prior to Screening, including but not limited to corticosteroid (oral, swallowed topical or parenteral), non-steroidal immunosuppressants (e.g., methotrexate, cyclosporin, tacrolimus, mycophenolate mofetil, azathioprine), other immunomodulators (e.g., Jak inhibitors, tyrosine kinase inhibitors), and investigational agents
- •Biologic therapy within 5 half-lives (or detectable serum level) prior to Screening, including but not limited to interleukin (IL)-4 receptor inhibitor (dupilumab), IL-5 inhibitors (e.g., mepolizumab, benralizumab), IL-13 inhibitors (e.g., tralokinumab, lebrikizumab), anti-IgE (e.g., omalizumab), IFN-γ inhibitors, or other approved or investigational biologics
- •Oral immunotherapy (OIT) within 6 months prior to Screening
- •Sublingual immunotherapy (SLIT) and/or subcutaneous immunotherapy (SCIT) Note: Not exclusionary if patient has been on a stable maintenance dose for at least 6 months prior to Screening
- •Receipt of a live vaccine within 2 months prior to the Baseline (Day 1) Visit (patients must agree to avoid live vaccination during study treatment and within 3 months thereafter).
- •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
- •Prior receipt of barzolvolimab
- •There may be additional criteria your study doctor will review with you to confirm eligibility
研究组 & 干预措施
Barzolvolimab (CDX-0159)
Active Comparator
300 mg subcutaneous administration every 4 weeks through week 24
干预措施: barzolvolimab (Biological)
Placebo then barzolvolimab (CDX-0159) 300mg
Placebo Comparator
Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
时间窗: From baseline to Visit 6 (Week 12)
Peak esophageal intraepithelial mast cell counts will be determined by counting mast cells in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as mast cells/hpf.
次要结局
- Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).(From baseline to Visit 6 (Week 12))
- Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.(From baseline to Visit 6 (Week 12))
- Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).(From baseline to Visit 6 (Week 12))
- Percent (%) change from baseline to Week 12 in PMC/hpf.(From baseline to Visit 6 (Week 12))
- Incidence of Treatment Emergent Adverse Events.(From first dose through Visit 14 (Week 44))
研究者
研究点 (85)
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