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NCT05370521 (Tildacerfont in Polycystic Ovary Syndrome): BVCT ex-ante prediction vs. reported outcome

On 7 Aug 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 3 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior).

Clinical Trial

NCTID
NCT05370521
Acronym
POWER
Drug Name
Tildacerfont
Drug MoA
CRF1R antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Polycystic Ovary Syndrome
Human Patients
27
Sponsor
Spruce Biosciences
Phase
Phase 2

Prediction of , index 910

Prospective Prediction
Prediction Index
910
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
301 days in advance
Readout Data Interpretation
significant reduction in DHEAS -12.4% vs placebo +5.7% was observed (p = 0.020; vs -12% by metformin).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of Tildacerfont in Adult Subjects With Polycystic Ovary Syndrome (PCOS) and Elevated Adrenal Androgens
Phase
Phase 2
Status
Terminated
Enrollment
27
Lead sponsor
Spruce Biosciences
Conditions
Polycystic Ovary Syndrome
Interventions
DRUG: Tildacerfont; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-05-15
Primary completion
2023-08-03
Completion
2023-08-31
Results first posted
2025-10-09
Primary outcomes
  • Change in DHEAS (12 weeks (assessed at Baseline, Weeks 4, 8 and 12))

NCT05370521 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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