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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05774184




Registration number
NCT05774184
Ethics application status
Date submitted
7/03/2023
Date registered
17/03/2023
Date last updated
27/06/2024

Titles & IDs
Public title
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Scientific 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)
Secondary ID [1] 0 0
2022-001786-12
Secondary ID [2] 0 0
CDX0159-08
Universal Trial Number (UTN)
Trial acronym
EvolvE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - barzolvolimab
Treatment: Drugs - Matching Placebo

Active comparator: Barzolvolimab (CDX-0159) - 300 mg subcutaneous administration every 4 weeks through week 24

Placebo comparator: Placebo then barzolvolimab (CDX-0159) 300mg - Matching placebo subcutaneous administration every 4 weeks through week 16, then 300mg subcutaneous administration every 4 weeks through week 24


Treatment: Other: barzolvolimab
subcutaneous administration

Treatment: Drugs: Matching Placebo
subcutaneous administration
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Timepoint [1] 0 0
From baseline to Visit 6 (Week 12)
Secondary outcome [1] 0 0
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
Timepoint [1] 0 0
From baseline to Visit 6 (Week 12)
Secondary outcome [2] 0 0
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC = 12/hpf.
Timepoint [2] 0 0
From baseline to Visit 6 (Week 12)
Secondary outcome [3] 0 0
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
Timepoint [3] 0 0
From baseline to Visit 6 (Week 12)
Secondary outcome [4] 0 0
Percent (%) change from baseline to Week 12 in PMC/hpf.
Timepoint [4] 0 0
From baseline to Visit 6 (Week 12)
Secondary outcome [5] 0 0
Incidence of Treatment Emergent Adverse Events.
Timepoint [5] 0 0
From first dose through Visit 14 (Week 44)

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Massachusetts
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New York
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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Tennessee
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United States of America
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Utah
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Canada
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Alberta
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Canada
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British Columbia
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Germany
State/province [20] 0 0
Augsburg
Country [21] 0 0
Germany
State/province [21] 0 0
Hannover
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Germany
State/province [23] 0 0
Magdeburg
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Italy
State/province [24] 0 0
Milano
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Italy
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Padova
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Salerno
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Italy
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Verona
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Poland
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Warszawa
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Poland
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Lódz
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Spain
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Alicante
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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Zaragoza
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United Kingdom
State/province [36] 0 0
London
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United Kingdom
State/province [37] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celldex Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Trial website
https://clinicaltrials.gov/study/NCT05774184
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Celldex Therapeutics
Address 0 0
Country 0 0
Phone 0 0
844-723-9363
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05774184