A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— EvolvE  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774184
• Other study ID #: CDX0159-08
• Secondary ID: 2022-001786-12
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Celldex Therapeutics
• Contact: Celldex Therapeutics
• Phone: 844-723-9363
• Email: info[@]celldex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.

Description:

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Biological:
• barzolvolimab
subcutaneous administration

Drug:
• Matching Placebo
subcutaneous administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

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)