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NCT05545111 (NBI-1117568 in Schizophrenia): BVCT ex-ante prediction vs. reported outcome

On 6 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 28 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05545111
Drug Name
NBI-1117568
Drug MoA
oral CHRM4 agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Schizophrenia
Human Patients
213
Sponsor
Neurocrine Biosciences
Phase
Phase 2

Prediction of , index 1661

Prospective Prediction
Prediction Index
1661
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PANSS and toxicity inferior to KarXT yet non-inferior/non-superior to emraclidine)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in PANSS at week 6 against placebo featuring moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
53 days in advance
Readout Data Interpretation
achieved 7.5 point placebo-adjusted improvement in PANSS score; inferior to the SoC KarXT that showed 11.6-point placebo-adjusted improvement in phase 3 studies.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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 to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Phase
Phase 2
Status
Completed
Enrollment
210
Lead sponsor
Neurocrine Biosciences
Conditions
Schizophrenia
Interventions
DRUG: NBI-1117568; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-10-04
Primary completion
2024-07-10
Completion
2024-07-10
Primary outcomes
  • Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6 (Baseline and Week 6)

NCT05545111 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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