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NCT04457336 (Tildacerfont in Congenital Adrenal Hyperplasia): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 13 Mar 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04457336
Acronym
CAHmelia-203
Drug Name
Tildacerfont
Drug MoA
oral small molecule CRF1R antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
Congenital Adrenal Hyperplasia
Human Patients
96
Sponsor
Spruce Biosciences
Phase
Phase 2

Prediction of , index 911

Prospective Prediction
Prediction Index
911
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
104 days in advance
Readout Data Interpretation
primary endpoint not met.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal Hyperplasia
Phase
Phase 2
Status
Terminated
Enrollment
96
Lead sponsor
Spruce Biosciences
Conditions
Congenital Adrenal Hyperplasia
Interventions
DRUG: Tildacerfont/Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-08-26
Primary completion
2024-02-09
Completion
2024-05-23
Results first posted
2025-07-08
Primary outcomes
  • To Evaluate the Effect of Tildacerfont in Reducing A4 in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Over 12 Weeks (Baseline and 12 weeks of treatment (Week 18))

NCT04457336 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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