NCT06882785 A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
| NCT ID | NCT06882785 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2028-09-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2025-06-10 with a primary completion date of 2028-09-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Eligibility Criteria
Inclusion Criteria * Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI). * Participants must have a PANSS total score between 80 and 120, inclusive. * Participants must have a CGI-S score of ≥ 4. Exclusion Criteria * Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening. * Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia. * Participants must not have any history or presence of clinically significant medical conditions. * Other protocol-defined Inclusion/Exclusion criteria apply.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06882785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06882785 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT06882785 currently recruiting?
Yes, NCT06882785 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06882785 trial being conducted?
This trial is being conducted at Kōnan, Japan, Nagoya, Japan, Toyoake, Japan, Toyoake, Japan and 11 additional locations.
Who is sponsoring the NCT06882785 clinical trial?
NCT06882785 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 250 participants.
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