Eosinophilic Esophagitis Clinical Trial
— EvolvEOfficial title:
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)
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | August 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria 1. = 18 years of age 2. Documented diagnosis of eosinophilic esophagitis (EoE) by endoscopy 3. 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 4. 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 5. On a stable diet which includes solid foods for = 2 months prior to Screening (and throughout the study) 6. 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) 7. Willing to be compliant with completion of daily questionnaire Key Exclusion Criteria 1. Diagnosed with hypereosinophilic syndrome or Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis) 2. History of clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis 3. Known active Helicobacter pylori infection 4. History of coagulation disorders, esophageal varices, achalasia, Crohn's disease, ulcerative colitis, or celiac disease 5. Esophageal dilation within 3 months prior to Screening 6. Prior esophageal or gastric surgery that would confound the assessments of EoE 7. 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 8. Avoiding solid foods or using a feeding tube 9. Regular use of antiplatelet and/or anticoagulant therapy 10. 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 11. 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-? inhibitors, or other approved or investigational biologics 12. Oral immunotherapy (OIT) within 6 months prior to Screening 13. 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 14. 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). 15. 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 16. Prior receipt of barzolvolimab There may be additional criteria your study doctor will review with you to confirm eligibility |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | St Vincent's Hospital Melbourne | Melbourne | |
Australia | The Alfred Hospital | Melbourne | Victoria |
Canada | University of Calgary | Calgary | Alberta |
Canada | PerCuro Clinical Research Ltd. | Victoria | British Columbia |
Germany | Universitaetsklinikum Augsburg | Augsburg | |
Germany | Klinikum Region Hannover GmbH Burgwedel | Hannover | |
Germany | Universitaetsklinikum Leipzig | Leipzig | |
Germany | Universitaetsklinikum Magdeburg A.oe.R. | Magdeburg | |
Italy | IRCCS Ospedale San Raffaele | Milano | |
Italy | Azienda Ospedale - Università Padova | Padova | |
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Rome | |
Italy | Istituto Clinico Humanitas | Rozzano | |
Italy | Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi" | Salerno | |
Italy | Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma | Verona | |
Poland | Centrum Medyczne Med-Gastr Sp. z o.o. | Lódz | |
Poland | Centrum Zdrowia MDM - EB Group Sp. z o.o | Warszawa | |
Poland | WIP Warsaw IBD Point Profesor Kierkus | Warszawa | |
Poland | Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob | Warszawa | |
Spain | Hospital General Universitario de Alicante Dr. Balmis | Alicante | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Corporacio Sanitaria Parc Tauli - Hospital de Sabadell | Sabadell | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United Kingdom | St George's Hospital | London | |
United Kingdom | St. Thomas' Hospital | London | |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
United States | AllerVie Clinical Research | Birmingham | Alabama |
United States | Treasure Valley Medical Research | Boise | Idaho |
United States | Boston Specialists - Boston Food Allergy Center | Boston | Massachusetts |
United States | Connecticut Clinical Research Institute, LLC | Bristol | Connecticut |
United States | University of North Carolina (UNC) Hospitals | Chapel Hill | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | GW Research Inc. | Chula Vista | California |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | University of Iowa | Iowa City | Iowa |
United States | ENCORE Borland Groover Clinical Research | Jacksonville | Florida |
United States | University of Florida (UF) - Jacksonville | Jacksonville | Florida |
United States | University of Kansas Medical Center (KUMC) | Kansas City | Kansas |
United States | Tandem Clinical Research | Marrero | Louisiana |
United States | Vanderbilt University Medical Center-GI Clinical Research Program | Nashville | Tennessee |
United States | NYU Langone Health | New York | New York |
United States | Advanced Research Institute - Ogden | Ogden | Utah |
United States | Gastroenterology of Greater Orlando | Orange City | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Care Access Research | Salt Lake City | Utah |
United States | University of Utah | Salt Lake City | Utah |
United States | One of a Kind Clinical Research Center | Scottsdale | Arizona |
United States | GI Alliance- Arizona Digestive Health- Sun City | Sun City | Arizona |
United States | Del Sol Research Management, LLC | Tucson | Arizona |
United States | The Clinical Trials Network, LLC | Willoughby | Ohio |
Lead Sponsor | Collaborator |
---|---|
Celldex Therapeutics |
United States, Australia, Canada, Germany, Italy, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf). | 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. | From baseline to Visit 6 (Week 12) | |
Secondary | Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ). | DSQ is a questionnaire designed to measure difficulty swallowing associated with Eosinophilic Esophagitis (EoE), with total scores ranging from 0 to 84; higher DSQ scores indicate worse symptoms. | From baseline to Visit 6 (Week 12) | |
Secondary | Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC = 12/hpf. | 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. | From baseline to Visit 6 (Week 12) | |
Secondary | Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf). | Peak esophageal intraepithelial eosinophils will be determined by counting eosinophils in the most inflamed high-power field (hpf) of each of the 3 esophageal (proximal, mid, distal) levels and reported as eosinophils/hpf. | From baseline to Visit 6 (Week 12) | |
Secondary | Percent (%) change from baseline to Week 12 in PMC/hpf. | 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. | From baseline to Visit 6 (Week 12) | |
Secondary | Incidence of Treatment Emergent Adverse Events. | The rates of treatment emergent adverse events will be summarized. | From first dose through Visit 14 (Week 44) |
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