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NCT04950127 (linerixibat in Cholestatic Pruritus): BVCT ex-ante prediction vs. reported outcome

On 13 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 19 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT04950127
Acronym
GLISTEN
Drug Name
linerixibat
Drug MoA
ASBT/IBAT inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Cholestatic Pruritus (CP)
Human Patients
238
Sponsor
GSK
Phase
Phase 3

Prediction of , index 1752

Prospective Prediction
Prediction Index
1752
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in cholestatic pruritus non-superior non-inferior to odevixibat/volixibat)
Technical Prediction
partial SUCCESS (statistically maybe significant yet moderate clinical benefit in cholestatic pruritus against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
98 days in advance
Readout Data Interpretation
linerixibat achieved the primary endpoint of itch score reduction at week 24 (no specific data or p-value disclosed)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)
Phase
Phase 3
Status
Completed
Enrollment
238
Lead sponsor
GlaxoSmithKline
Conditions
Pruritus
Interventions
DRUG: Linerixibat; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-08-27
Primary completion
2024-10-28
Completion
2024-12-20
Results first posted
2025-07-22
Primary outcomes
  • Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) (Baseline and up to Week 24)

NCT04950127 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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