NCT07686263 Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
| NCT ID | NCT07686263 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 472 participants |
| Start Date | 2026-08-20 |
| Primary Completion | 2029-03-03 |
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 472 participants in total. It began in 2026-08-20 with a primary completion date of 2029-03-03.
⚠ 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 the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Eligibility Criteria
Inclusion Criteria * Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. * Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. * Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. * Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) * Participant must have a CGI-S score of ≥ 4 at screening and Day -1 * Participant must have a BMI ≥ 18 and ≤ 40 kg/m2. Exclusion Criteria * Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening * Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. * Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). * Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. * Participant must not have a history of treatment resistance to schizophrenia medications * Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. * 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 NCT07686263 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 NCT07686263 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 472 participants.
Is NCT07686263 currently recruiting?
Yes, NCT07686263 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07686263 trial being conducted?
This trial is being conducted at Bentonville, United States, Little Rock, United States, Little Rock, United States, Rogers, United States and 11 additional locations.
Who is sponsoring the NCT07686263 clinical trial?
NCT07686263 is sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 472 participants.
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