Eosinophilic EsophagitisPhase 2EvolvENCT05774184
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
A Phase 2 study testing barzolvolimab in people with Eosinophilic Esophagitis, run by Celldex Therapeutics at 45 sites in 8 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- barzolvolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 45 sitesin 8 countries
- Study dates
- 1 Jun 2023to 23 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
45 sites in 8 countries.
45 sites in 8 countries
United States24 sites
AllerVie Clinical Research
Birmingham, Alabama, 35209
Treasure Valley Medical Research
Boise, Idaho, 83706
Boston Specialists - Boston Food Allergy Center
Boston, Massachusetts, 02111
Connecticut Clinical Research Institute, LLC
Bristol, Connecticut, 06416
University of North Carolina (UNC) Hospitals
Chapel Hill, North Carolina, 27514
Northwestern University
Chicago, Illinois, 60208
GW Research Inc.
Chula Vista, California, 91910
Duke University Medical Center
Durham, North Carolina, 27710
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160
Tandem Clinical Research
Marrero, Louisiana, 70072
Vanderbilt University Medical Center-GI Clinical Research Program
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
Advanced Research Institute - Ogden
Ogden, Utah, 84405
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Care Access Research
Salt Lake City, Utah, 84124
University of Utah
Salt Lake City, Utah, 84132
One of a Kind Clinical Research Center
Scottsdale, Arizona, 85258
GI Alliance- Arizona Digestive Health- Sun City
Sun City, Arizona, 85351
Del Sol Research Management, LLC
Tucson, Arizona, 85715
The Clinical Trials Network, LLC
Willoughby, Ohio, 44096
Italy5 sites
IRCCS Ospedale San Raffaele
Milan
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona-Plesso "Ruggi"
Salerno
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia
The Alfred Hospital
Melbourne, Victoria
St Vincent's Hospital Melbourne
Melbourne
Germany3 sites
Universitaetsklinikum Augsburg
Augsburg
Klinikum Region Hannover GmbH Burgwedel
Hanover
Universitaetsklinikum Magdeburg A.oe.R.
Magdeburg
Poland3 sites
Centrum Medyczne Med-Gastr Sp. z o.o.
Lodz
WIP Warsaw IBD Point Profesor Kierkus
Warsaw
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob
Warsaw
United Kingdom3 sites
St George's Hospital
London
St. Thomas' Hospital
London
Norfolk and Norwich University Hospital
Norwich
Canada2 sites
University of Calgary
Calgary, Alberta
PerCuro Clinical Research Ltd.
Victoria, British Columbia
Spain2 sites
Hospital General Universitario de Alicante Dr. Balmis
Alicante
Hospital Clinico San Carlos
Madrid
About this study
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)
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Read the detailed description
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- barzolvolimab, Matching Placebo
- Keywords
- barzolvolimab, esophagitis, EoE, mast cells, CDX-0159
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barzolvolimabBiological
Also called CDX-0159
subcutaneous administration
Matching PlaceboDrug
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Barzolvolimab (CDX-0159) | Active comparator | 300 mg subcutaneous administration every 4 weeks through week 24 Receives: Biological: barzolvolimab |
| 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 Receives: Biological: barzolvolimab; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Visit 6 (Week 12)
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: From baseline to Visit 6 (Week 12)
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.
Measured: From baseline to Visit 6 (Week 12)
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.
Measured: From baseline to Visit 6 (Week 12)
Incidence of Treatment Emergent Adverse Events.
The rates of treatment emergent adverse events will be summarized.
Measured: From first dose through Visit 14 (Week 44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jun 2023
- Primary completion4 Jun 2025
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774184
- Sponsor's protocol ID
- CDX0159-08
- Other IDs
- 2022-001786-12, 2024-512767-30-00
- Acronym
- EvolvE
- Status last verified
- May 2026
- First submitted
- 7 Mar 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05774184
- Acronym / sponsor ID
- EvolvE / CDX0159-08
- Conditions
- Eosinophilic Esophagitis
- Keywords
- barzolvolimab, esophagitis, EoE, mast cells, CDX-0159
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barzolvolimab (CDX-0159) | Active comparator | Biological: barzolvolimab300 mg subcutaneous administration every 4 weeks through week 24 |
| Placebo then barzolvolimab (CDX-0159) 300mg | Placebo comparator | Biological: barzolvolimab, Drug: Matching PlaceboMatching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| barzolvolimabAlso: CDX-0159subcutaneous administration | Biological | Barzolvolimab (CDX-0159), Placebo then barzolvolimab (CDX-0159) 300mg |
| Matching Placebosubcutaneous administration | Drug | Placebo then barzolvolimab (CDX-0159) 300mg |
Primary outcome
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.
5 secondary outcomes
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
Time frame: 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.
Time frame: From baseline to Visit 6 (Week 12)
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
Time frame: From baseline to Visit 6 (Week 12)
Percent (%) change from baseline to Week 12 in PMC/hpf.
Time frame: From baseline to Visit 6 (Week 12)
Incidence of Treatment Emergent Adverse Events.
Time frame: From first dose through Visit 14 (Week 44)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing barzolvolimab in people with Eosinophilic Esophagitis, run by Celldex Therapeutics at 45 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Italy, Australia, Germany, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.