BridgeMD
A Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The "EvolvE" Study)
EU CTIS ID: 2024-512767-30-00
What this study is testing
To evaluate efficacy of barzolvolimab, compared to placebo, in reducing esophageal intraepithelial infiltration of mast cells as assessed by peak esophageal intraepithelial mast cell (PMC) count in EoE patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1 - Read, understood, and provided written informed consent, after the nature of the study has been fully explained.
- 2 - Male or female, ≥ 18 years of age at the time of signing the informed consent
- 3 - Documented diagnosis of EoE by endoscopy consent
- 4 - Esophageal intraepithelial eosinophilic infiltration, with 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 at the Screening/Baseline esophagogastroduodenoscopy (EGD) at the Screening Visit.
- 5 - Must be symptomatic, defined as: a. History (by patient report) of an average of at least 2 days per week with dysphagia with intake of solid foods during 1 month prior to the Screening Visit and b. At least 4 days with dysphagia (answer of "Yes" to DSQ Question #2) within the last 2 weeks immediately prior to randomization.
- 6 - Must have been on a stable diet which includes solid foods for at least 2 months prior to the Screening Visit and throughout the study. Note: Stable diet is defined as no initiation or elimination of single or multiple food groups or reintroduction of previously eliminated food groups.
You likely can't join if
- 1 - Diagnosis of hypereosinophilic syndrome or Churg-Strauss syndrome (or eosinophilic granulomatosis with polyangiitis).
- 10 - 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; or any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines.
- 11 - Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting study treatment.
- 2 - History of a clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis.
- 3 - Known active Helicobacter pylori infection
- 4 - History of coagulation disorders or esophageal varices
See the full eligibility criteria
Who can join
- 1 - Read, understood, and provided written informed consent, after the nature of the study has been fully explained.
- 2 - Male or female, ≥ 18 years of age at the time of signing the informed consent
- 3 - Documented diagnosis of EoE by endoscopy consent
- 4 - Esophageal intraepithelial eosinophilic infiltration, with 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 at the Screening/Baseline esophagogastroduodenoscopy (EGD) at the Screening Visit.
- 5 - Must be symptomatic, defined as: a. History (by patient report) of an average of at least 2 days per week with dysphagia with intake of solid foods during 1 month prior to the Screening Visit and b. At least 4 days with dysphagia (answer of "Yes" to DSQ Question #2) within the last 2 weeks immediately prior to randomization.
- 6 - Must have been on a stable diet which includes solid foods for at least 2 months prior to the Screening Visit and throughout the study. Note: Stable diet is defined as no initiation or elimination of single or multiple food groups or reintroduction of previously eliminated food groups.
- 7 - Have had 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) based on the investigator's clinical judgment.
What rules you out
- 1 - Diagnosis of hypereosinophilic syndrome or Churg-Strauss syndrome (or eosinophilic granulomatosis with polyangiitis).
- 10 - 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; or any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines.
- 11 - Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting study treatment.
- 2 - History of a clinicopathologic diagnosis of eosinophilic gastritis or eosinophilic duodenitis.
- 3 - Known active Helicobacter pylori infection
- 4 - History of coagulation disorders or esophageal varices
- 5 - History of achalasia, Crohn's disease, ulcerative colitis or celiac disease
- 6 - Esophageal dilation within 3 months prior to the Screening Visit or a planned/elective esophageal dilation anytime during the study.
- 7 - Avoiding solid foods or using feeding tube
- 8 - Non-biologic systemic (oral or injectable) agents within 4 weeks or 5 half-lives, whichever is longer, prior to the Screening Visit.
- 9 - Biologic therapy within 5 half-lives (or detectable serum level), prior to the Screening Visit. Note: Biologic agents include but are not limited to interleukin (IL)-4 receptor inhibitor (dupilumab), IL-5 inhibitors (e.g., mepolizumab, benralizumab), IL-13 inhibitors (e.g., tralokinumab, lebrikizumab), antiIgE (e.g., omalizumab), IFN-γ inhibitors, or other approved or investigational biologics.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.