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NCT05145413 (Adjunctive KarXT in treatment-resistant schizophrenia): BVCT ex-ante prediction vs. reported outcome

On 2 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Apr 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05145413
Acronym
ARISE
Drug Name
Adjunctive KarXT
Drug MoA
fixed-dose combination of xanomeline and trospium chloride KarXT
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
treatment-resistant schizophrenia
Human Patients
396
Sponsor
Bristol-Myers Squibb
Phase
Phase 3

Prediction of , index 1958

Prospective Prediction
Prediction Index
1958
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in PANSS moderately superior to lumateperone)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in PANSS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
20 days in advance
Readout Data Interpretation
KarXT + SoC failed to deliver additional clinical benefit in PANSS total score at week 6 compared with SoC alone
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease modelling of schizophrenia not uncontrollable by standard therapies; which has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Phase
Phase 3
Status
Completed
Enrollment
396
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions
Schizophrenia
Interventions
DRUG: Xanomeline and Trospium Chloride Capsules; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-11-12
Primary completion
2025-03-19
Completion
2025-03-19
Results first posted
2026-05-05
Primary outcomes
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Baseline to Week 6)

NCT05145413 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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