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NCT05405660 (Barzolvolimab Matching Placebo in Chronic Inducible Urticaria): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Jul 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05405660
Drug Name
Barzolvolimab Matching Placebo
Drug MoA
KIT receptor tyrosine kinase inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Chronic Inducible Urticaria
Human Patients
196
Sponsor
Celldex Therapeutics
Phase
Phase 2

Prediction of , index 861

Prospective Prediction
Prediction Index
861
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
345 days in advance
Readout Data Interpretation
CDX0159 achieved 40.6% placebo-adjusted CR.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria
Phase
Phase 2
Status
Completed
Enrollment
196
Lead sponsor
Celldex Therapeutics
Conditions
Chronic Inducible Urticaria
Interventions
BIOLOGICAL: barzolvolimab; DRUG: Matching Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-28
Primary completion
2024-06-12
Completion
2025-09-12
Primary outcomes
  • Percentage of patients with a negative provocation test at week 12 (From baseline to week 12)

NCT05405660 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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