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NCT04544410 (Tildacerfont in Adult 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 10 Dec 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
NCT04544410
Acronym
CAHmelia-204
Drug Name
Tildacerfont
Drug MoA
CRF1R antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
Adult Congenital Adrenal Hyperplasia (CAH)
Human Patients
90
Sponsor
Spruce Biosciences
Phase
Phase 2

Prediction of , index 913

Prospective Prediction
Prediction Index
913
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
376 days in advance
Readout Data Interpretation
ildacerfont did not achieve statistical significance in GC level reduction
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 Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects With Classic Congenital Adrenal Hyperplasia
Phase
Phase 2
Status
Terminated
Enrollment
100
Lead sponsor
Spruce Biosciences
Conditions
Congenital Adrenal Hyperplasia
Interventions
DRUG: Tildacerfont/Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-02-22
Primary completion
2024-10-31
Completion
2025-01-31
Results first posted
2025-10-01
Primary outcomes
  • Change in Total Daily GC Dose in Subjects With Classic CAH Over the 24-week, Double Blind, Placebo-Controlled Treatment Period (24 Weeks)

NCT04544410 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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