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Monoclonal Antibodies

Barzolvolimab for Eosinophilic Esophagitis (EvolvE Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
On a stable diet which includes solid foods for ≥ 2 months prior to Screening (and throughout the study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose through visit 14 (week 44)
Awards & highlights

EvolvE Trial Summary

This trial looks at a drug to help adults with Eosinophilic Esophagitis, to see if it's safe and effective.

Who is the study for?
Adults with Eosinophilic Esophagitis who experience swallowing difficulties at least twice a week, have not responded well to standard treatments, and can complete daily questionnaires. They must not have certain other digestive or allergic conditions, recent esophageal procedures, or be on specific medications.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of barzolvolimab compared to a placebo in treating adults with Eosinophilic Esophagitis. Participants will receive either the actual drug or a placebo without knowing which one they are getting.See study design
What are the potential side effects?
Potential side effects of barzolvolimab may include allergic reactions similar to those experienced with other biologic therapies. Specific side effects for this drug are not listed but could align with common infusion-related reactions.

EvolvE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
Standard treatments for my EoE did not work or were not suitable for me.

EvolvE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose through visit 14 (week 44)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through visit 14 (week 44) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).
Secondary outcome measures
Absolute change from baseline to Week 12 in Peak esophageal intraepithelial eosinophil count (PEC) (PEC/hpf).
Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf) among patients with baseline PMC ≥ 12/hpf.
Absolute changes from baseline to Week 12 in Dysphagia Symptom Questionnaire (DSQ).
+2 more

EvolvE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Barzolvolimab (CDX-0159)Active Control1 Intervention
300 mg subcutaneous administration every 8 weeks through week 24
Group II: Placebo then barzolvolimab (CDX-0159) 300mgPlacebo Group1 Intervention
Matching placebo subcutaneous administration every 8 weeks through week 16, then 300mg subcutaneous administration every 8 weeks through week 24

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
61 Previous Clinical Trials
3,890 Total Patients Enrolled

Media Library

barzolvolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05774184 — Phase 2
Eosinophilic Esophagitis Research Study Groups: Barzolvolimab (CDX-0159), Placebo then barzolvolimab (CDX-0159) 300mg
Eosinophilic Esophagitis Clinical Trial 2023: barzolvolimab Highlights & Side Effects. Trial Name: NCT05774184 — Phase 2
barzolvolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05774184 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target participant count for this experiment?

"The medical study necessitates 60 appropriate candidates. Eligible patients can enroll at Treasure Valley Medical Research in Boise, Idaho or Tandem Clinical Research in Marrero, Louisiana."

Answered by AI

Are there still opportunities to be included in this experiment?

"Affirmative. Clinicaltrials.gov records reveal this clinical investigation is actively enrolling members; the first posting was on June 1st 2023 and a subsequent edit occurred on that same day. All in all, 60 patients from 3 different sites need to be recruited for this trial."

Answered by AI

What potential risks does the use of Barzolvolimab (CDX-0159) carry?

"Our Power team rated Barzolvolimab (CDX-0159) a 2 on our safety scale due to its Phase 2 trial status, which implies that there is evidence of the drug's security but not of its effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
2023. "A Study of CDX-0159 in Patients With Eosinophilic Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05774184.
All > Eosinophilic Esophagitis > Meridian
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