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NCT03697109 (Relacorilant in Cushing Syndrome): BVCT ex-ante prediction vs. reported outcome

On 22 Oct 2022, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically borderline significant and commercially insufficient.

Clinical Trial

NCTID
NCT03697109
Acronym
GRACE
Drug Name
Relacorilant
Drug MoA
oral non-steroidal glucocorticoid receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Endocrine System Diseases
Indication
Cushing Syndrome
Human Patients
152
Sponsor
Corcept Therapeutics
Phase
Phase 3

Prediction of , index 543

Prospective Prediction
Prediction Index
543
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in the randomized-withdrawal phase)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in the randomized-withdrawal phase)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
594 days in advance
Readout Data Interpretation
primary endpoint loss of response met with borderline statistical significance (p=0.02) secondary endpoint 24h SBP achieved statistical significance (P-0.0025) yet 24h DBP didn't achieve statistical significance (P=0.046); neither body weight (P=0.09) nor HbA1c (P=0.04) achieved statistical significance.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically borderline significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant
Phase
Phase 3
Status
Completed
Enrollment
152
Lead sponsor
Corcept Therapeutics
Conditions
Cushing Syndrome
Interventions
DRUG: Relacorilant; OTHER: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2018-11-15
Primary completion
2024-04-08
Completion
2024-04-15
Results first posted
2025-04-24
Primary outcomes
  • Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. (Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase))
  • Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. (OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase)

NCT03697109 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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