NCT05774184CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Celldex Therapeutics
- Enrollment
- 86
- Locations
- 85
- Primary Endpoint
- Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Detailed Description
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 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
Exclusion Criteria
- •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
Arms & Interventions
Barzolvolimab (CDX-0159)
Active Comparator
300 mg subcutaneous administration every 4 weeks through week 24
Intervention: 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
Intervention: Matching Placebo (Drug)
Outcomes
Primary Outcomes
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
Study Sites (85)
Loading locations...
Similar Trials
Active, not recruiting
Phase 2
A Study of Barzolvolimab in Patients With Prurigo NodularisPrurigo NodularisNCT06366750Celldex Therapeutics140
Active, not recruiting
Phase 2
A Study of Barzolvolimab in Patients With Atopic DermatitisAtopic DermatitisNCT06727552Celldex Therapeutics131
Active, not recruiting
Phase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous UrticariaChronic Spontaneous UrticariaNCT06445023Celldex Therapeutics963
Recruiting
Phase 3
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)Chronic Spontaneous UrticariaNCT06455202Celldex Therapeutics915
Completed
Phase 4
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonistsAllergic AsthmaNCT00670930Novartis Pharmaceuticals36