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NCT05128942 (Tildacerfont in pediatric 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
NCT05128942
Acronym
CAHptain-205
Drug Name
Tildacerfont
Drug MoA
CRF1R antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
pediatric Congenital Adrenal Hyperplasia (CAH)
Human Patients
70
Sponsor
Spruce Biosciences
Phase
Phase 2

Prediction of , index 912

Prospective Prediction
Prediction Index
912
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
tildacerfont did not achieve statistical significance in A4/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 Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of SPR001 (Tildacerfont) in Children Aged 2 to 17 Years With Congenital Adrenal Hyperplasia (CAH)
Phase
Phase 2
Status
Terminated
Enrollment
67
Lead sponsor
Spruce Biosciences
Conditions
Congenital Adrenal Hyperplasia; 21-OHD
Interventions
DRUG: Tildacerfont
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-12-10
Primary completion
2025-01-31
Completion
2025-01-31
Results first posted
2025-12-24
Primary outcomes
  • Number of Participants With Treatment-emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (12 weeks)

NCT05128942 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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