Eosinophilic esophagitis (EoE) MedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: barzolvolimab
Product Code: CDX-0159
Pharmaceutical Form: Solution for injection
INN or Proposed INN: barzolvolimab
CAS Number: 2438203-51-9
Current Sponsor code: CDX-0159
Other descript
Sponsors
Celldex Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 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. Are the trial subjects under 18? no 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Diagnosis of hypereosinophilic syndrome or Churg-Strauss syndrome (or eosinophilic granulomatosis with polyangiitis). 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • To evaluate the efficacy of barzolvolimab, compared to placebo, in reducing symptoms of dysphagia as assessed by dysphagia symptom questionnaire (DSQ) in EoE patients • 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 • 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);Timepoint(s) of evaluation of this end point: Screening (baseline), week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Absolute changes from baseline to Week 12 in DSQ • Absolute change from baseline to Week 12 in PMC/hpf among patients with baseline PMC = 12/hpf • Absolute change from baseline to Week 12 in PEC/hpf • Percent (%) change from baseline to week 12 in PMC7hpf • Incidence of TEAEs;Timepoint(s) of evaluation of this end point: Screening (baseline), week 12 TEAEs: continuously until end of study visit. | — |
Countries
Australia, Canada, Germany, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Celldex Therapeutics, Inc.
Outcome results
None listed