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NCT05525520 (INCB000547 in Cholestatic Pruritus): BVCT ex-ante prediction vs. reported outcome

On 28 Apr 2024, BioinvestGPT's BVCT predicted technical partial success 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
NCT05525520
Acronym
PACIFIC
Drug Name
INCB000547 (EP547)
Drug MoA
MRGPRX4 antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Cholestatic Pruritus (CP)
Human Patients
62
Sponsor
Incyte Corporation
Phase
Phase 2

Prediction of , index 1575

Prospective Prediction
Prediction Index
1575
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with inferior-to-SoC efficacy in cholestatic pruritus reduction)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit in cholestatic pruritus reduction with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
204 days in advance
Readout Data Interpretation
INCB000547's further development will be discontinued due to weak clinical benefit (no detailed data disclosure)
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
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Phase
Phase 2
Status
Completed
Enrollment
62
Lead sponsor
Escient Pharmaceuticals, Inc
Conditions
Pruritus
Interventions
DRUG: EP547; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-10-06
Primary completion
2024-07-17
Completion
2024-09-05
Results first posted
2025-07-31
Primary outcomes
  • Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6 (Baseline; up to Week 6)

NCT05525520 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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