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NCT06077773 (INCB000262 in chronic spontaneous urticaria): BVCT ex-ante prediction vs. reported outcome

On 28 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 18 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06077773
Acronym
CALM-CSU
Drug Name
INCB000262 (EP262)
Drug MoA
MRGPRX2 antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
chronic spontaneous urticaria (CSU)
Human Patients
154
Sponsor
Incyte Corporation
Phase
Phase 2

Prediction of , index 1584

Prospective Prediction
Prediction Index
1584
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with inferior-to-barzolvolimab efficacy)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
204 days in advance
Readout Data Interpretation
enrolment paused due to preclinical toxicity findings of INCB000262
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
Phase
Phase 2
Status
Terminated
Enrollment
113
Lead sponsor
Escient Pharmaceuticals, Inc
Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG: Oral EP262; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2023-09-25
Primary completion
2024-12-18
Completion
2025-01-16
Results first posted
2025-12-05
Primary outcomes
  • Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7) (Baseline; Week 6)

NCT06077773 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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