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NCT05804045 (Pimicotinib in tenosynovial giant cell tumor): BVCT ex-ante prediction vs. reported outcome

On 14 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 12 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient; correct prediction.

Clinical Trial

NCTID
NCT05804045
Acronym
MANEUVER
Drug Name
Pimicotinib(ABSK021)
Drug MoA
anti-CSF1R inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
tenosynovial giant cell tumor (TGCT)
Human Patients
90
Sponsor
Merck KGaA
Phase
Phase 3

Prediction of , index 1616

Prospective Prediction
Prediction Index
1616
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to pexidartinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
182 days in advance
Readout Data Interpretation
pimicotinib achieved 50.8% placebo-adjusted ORR at week 25 (p<0.0001); which is superior to pexidartinib's 39% placebo-adjusted ORR at week 25 (P<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient; correct prediction
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor
Phase
Phase 3
Status
Active not recruiting
Enrollment
94
Lead sponsor
Abbisko Therapeutics Co, Ltd
Conditions
Tenosynovial Giant Cell Tumor; Pigmented Villonodular Synovitis; Giant Cell Tumor of Tendon Sheath
Interventions
DRUG: Pimicotinib(ABSK021); DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-04-27
Primary completion
2024-09-23
Completion
2028-06
Results first posted
2026-05-04
Primary outcomes
  • Objective Response Rate (ORR) (Baseline to Week 25)

NCT05804045 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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