CompletedPhase 2

A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

United States86 participantsStarted 2023-06-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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

✕. 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

Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).

Timeframe: From baseline to Visit 6 (Week 12)

NCT IDNCT05774184

SponsorCelldex Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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

✕. 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