BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05407324 (Dazucorilant in Amyotrophic Lateral Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 14 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 11 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
NCT05407324
Acronym
DAZALS
Drug Name
Dazucorilant
Drug MoA
lipid selective glucocorticoid receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Amyotrophic Lateral Sclerosis (ALS)
Human Patients
249
Sponsor
Corcept Therapeutics
Phase
Phase 2

Prediction of , index 551

Prospective Prediction
Prediction Index
551
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
241 days in advance
Readout Data Interpretation
dazucorilant failed to achieve its primary efficacy endpoint
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, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
Phase
Phase 2
Status
Active not recruiting
Enrollment
279
Lead sponsor
Corcept Therapeutics
Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG: Dazucorilant 300 mg; DRUG: Dazucorilant 150 mg; OTHER: Placebo; DRUG: Dazucorilant
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-11-15
Primary completion
2026-10
Completion
2027-11
Primary outcomes
  • Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. (Baseline to Week 24)
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs (Baseline to Week 24)
  • Incidence of treatment-emergent AEs and SAEs (Baseline up to Week 12)
  • Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug (Baseline up to Week 12)

NCT05407324 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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