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A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

PHASE2RECRUITING

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

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Study details:

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

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

≥ 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

Exclusion criteria

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-06-01

Primary completion: 2025-03-01

Study completion finish: 2025-08-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05774184

Intervention or treatment

BIOLOGICAL: barzolvolimab

DRUG: Matching Placebo

Conditions

• Eosinophilic Esophagitis

Image related to Eosinophilic Esophagitis

Condition: Eosinophilic Esophagitis
BIOLOGICAL: barzolvolimab and other drugs
Adelaide, South Australia, Australia and more
Sponsor: Celldex Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Barzolvolimab (CDX-0159) 300 mg subcutaneous administration every 4 weeks through week 24	BIOLOGICAL: barzolvolimab subcutaneous administration
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	DRUG: Matching Placebo subcutaneous administration

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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)
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)
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)
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)
Incidence of Treatment Emergent Adverse Events.	The rates of treatment emergent adverse events will be summarized.	From first dose through Visit 14 (Week 44)

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study of CDX-0159 in Patients With Eosinophilic Esophagitis