Clinical trial NCT05774184: A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: barzolvolimab
esophagitis
EoE
mast cells
CDX-0159
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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-γ 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

Primary outcomes:
measure: Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
timeFrame: From baseline to Visit 6 (Week 12)
Secondary outcomes:
measure: Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
timeFrame: From baseline to Visit 6 (Week 12)
measure: Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.
timeFrame: From baseline to Visit 6 (Week 12)
measure: Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
timeFrame: From baseline to Visit 6 (Week 12)
measure: Percent (%) change from baseline to Week 12 in PMC/hpf.
timeFrame: From baseline to Visit 6 (Week 12)
measure: Incidence of Treatment Emergent Adverse Events.
timeFrame: From first dose through Visit 14 (Week 44)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: One of a Kind Clinical Research Center
state: Arizona
city: Sun City
country: United States
facility: GI Alliance- Arizona Digestive Health- Sun City
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Chula Vista
country: United States
facility: GW Research Inc.
state: California
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida (UF) - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland Groover Clinical Research
state: Florida
city: Orange City
country: United States
facility: Gastroenterology of Greater Orlando
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Boston Specialists - Boston Food Allergy Center
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Willoughby
country: United States
facility: The Clinical Trials Network, LLC
state: Ohio
city: Hershey
country: United States
facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-GI Clinical Research Program
state: Tennessee
city: Ogden
country: United States
facility: Advanced Research Institute - Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Care Access Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Augsburg
country: Germany
facility: Universitaetsklinikum Augsburg
city: Hannover
country: Germany
facility: Klinikum Region Hannover GmbH Burgwedel
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R.
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"
city: Verona
country: Italy
facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM - EB Group Sp. z o.o
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
city: Łódź
country: Poland
facility: Centrum Medyczne Med-Gastr Sp. z o.o.
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Dr. Balmis
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
References: