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NCT05774184 (Barzolvolimab in Eosinophilic Esophagitis): BVCT ex-ante prediction vs. reported outcome

On 15 May 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 19 Aug 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05774184
Acronym
EvolvE
Drug Name
Barzolvolimab (CDX-0159)
Drug MoA
anti-cKIT inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Eosinophilic Esophagitis (EoE)
Human Patients
86
Sponsor
Celldex Therapeutics
Phase
Phase 2

Prediction of , index 1207

Prospective Prediction
Prediction Index
1207
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in DSQ slightly superior to dupilumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in DSQ compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
96 days in advance
Readout Data Interpretation
barzolvolimab failed to achieve the primary efficacy endpoint in DSQ (p=0.33)
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease model that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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)
Phase
Phase 2
Status
Completed
Enrollment
86
Lead sponsor
Celldex Therapeutics
Conditions
Eosinophilic Esophagitis
Interventions
BIOLOGICAL: barzolvolimab; DRUG: Matching Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-06-01
Primary completion
2025-06-04
Completion
2026-01-23
Primary outcomes
  • Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf). (From baseline to Visit 6 (Week 12))

NCT05774184 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials