A Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The EvolvE Study)
- Conditions
- Eosinophilic EsophagitisMedDRA version: 20.1Level: LLTClassification code: 10064220Term: Eosinophilic esophagitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2024-512767-30-00
- Lead Sponsor
- Celldex Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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.
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-? inhibitors, or other approved or investigational biologics.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: 1 - To evaluate the efficacy of barzolvolimab, compared to placebo, in reducing symptoms of dysphagia as assessed by dysphagia symptom questionnaire (DSQ) in EoE patients, 2- To evaluate efficacy of barzolvolimab, compared to placebo, in reducing esophageal intraepithelial infiltration of eosinophils as assessed by peak esophageal intraepithelial eosinophil (PEC) count in EoE patients, 3 - To evaluate the safety profile of barzolvolimab in EoE patients;Primary end point(s): Absolute change from baseline to Week 12 in the PMC/high power field (hpf)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1 - Absolute changes from baseline to Week 12 in DSQ;Secondary end point(s):2 - Absolute change from baseline to Week 12 in PMC/hpf among patients with baseline PMC = 12/hpf;Secondary end point(s):3 - Absolute change from baseline to Week 12 in PEC/hpf;Secondary end point(s):4 - Percent (%) change from baseline to week 12 in PMC/hpf;Secondary end point(s):5 - Incidence of TEAEs