Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

NCT07686263 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: CN012-00062025-523664-20U1111-1327-75992025
• Study Type: interventional
• Target: 472
• Locations: 9 countries
• Sites: 59

Brief Summary

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Conditions

Schizophrenia

Keywords

KarXT; Cobenfy

Outcome Measures

Primary Outcomes (1)

• Time From Randomization to the First Relapse Event

  Up to approximately Week 43

Secondary Outcomes (6)

• Time to Discontinuation During Double-blind Treatment Period

  Approximately From Week 18 to 43

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to approximately Week 45

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Up to approximately Week 45

• Number of Participants With Procholinergic Symptoms

  Up to approximately Week 45

• Number of Participants With Anticholinergic Symptoms

  Up to approximately Week 45

Study Arms (2)

KarXT

EXPERIMENTAL

Drug: Xanomeline/Trospium Chloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Xanomeline/Trospium Chloride DRUG

Specified dose on specified days

Also known as: KarXT, BMS-986510

KarXT

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Item 1 (P1; delusions)
• Item 2 (P2; conceptual disorganization)
• Item 3 (P3; hallucinatory behavior)
• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (59)

Pillar Clinical Research - Bentonville

Bentonville, Arkansas, 72712, United States

RECRUITING

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, 72204, United States

RECRUITING

Local Institution - 0021

Little Rock, Arkansas, 72211, United States

NOT YET RECRUITING

Local Institution - 0153

Rogers, Arkansas, 72758, United States

NOT YET RECRUITING

Local Institution - 0190

Anaheim, California, 92805, United States

NOT YET RECRUITING

Local Institution - 0040

Bellflower, California, 90706, United States

NOT YET RECRUITING

Local Institution - 0188

Chino, California, 91710, United States

NOT YET RECRUITING

Local Institution - 0032

Culver City, California, 90230, United States

NOT YET RECRUITING

Local Institution - 0037

Garden Grove, California, 92845, United States

NOT YET RECRUITING

Local Institution - 0068

La Habra, California, 90631, United States

NOT YET RECRUITING

Local Institution - 0128

Lemon Grove, California, 91945, United States

NOT YET RECRUITING

Local Institution - 0187

Montclair, California, 91763, United States

NOT YET RECRUITING

Local Institution - 0151

Orange, California, 92868, United States

NOT YET RECRUITING

Local Institution - 0030

Pico Rivera, California, 90660, United States

NOT YET RECRUITING

Local Institution - 0185

Redlands, California, 92373, United States

NOT YET RECRUITING

Local Institution - 0186

Riverside, California, 92506, United States

NOT YET RECRUITING

Local Institution - 0193

Torrance, California, 90504, United States

NOT YET RECRUITING

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

RECRUITING

Local Institution - 0075

Miami, Florida, 33135, United States

WITHDRAWN

Local Institution - 0054

Miami Lakes, Florida, 33016, United States

WITHDRAWN

Local Institution - 0134

Miami Springs, Florida, 33166, United States

WITHDRAWN

Local Institution - 0195

Oakland Park, Florida, 33334, United States

NOT YET RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Local Institution - 0070

Sandy Springs, Georgia, 30328, United States

NOT YET RECRUITING

Local Institution - 0189

Savannah, Georgia, 31405, United States

NOT YET RECRUITING

Local Institution - 0067

Chicago, Illinois, 60640-5017, United States

NOT YET RECRUITING

Pillar Clinical Research -Chicago

Chicago, Illinois, 60641, United States

RECRUITING

Local Institution - 0192

Gaithersburg, Maryland, 20877, United States

NOT YET RECRUITING

Local Institution - 0183

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Local Institution - 0047

Oklahoma City, Oklahoma, 73112, United States

NOT YET RECRUITING

Local Institution - 0049

Austin, Texas, 78754, United States

NOT YET RECRUITING

Local Institution - 0194

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Pillar Clinical Research - Richardson

Richardson, Texas, 75080, United States

RECRUITING

Local Institution - 0175

Río Cuarto, Córdoba Province, 5800, Argentina

WITHDRAWN

Local Institution - 0143

Buenos Aires, C1199ABB, Argentina

WITHDRAWN

Local Institution - 0002

Córdoba, 5000, Argentina

NOT YET RECRUITING

Local Institution - 0144

Santiago del Estero, 4200, Argentina

NOT YET RECRUITING

Local Institution - 0191

Novi Iskar, 1282, Bulgaria

NOT YET RECRUITING

Local Institution - 0162

Brno, 625 00, Czechia

NOT YET RECRUITING

Local Institution - 0014

Klecany, 25067, Czechia

NOT YET RECRUITING

Local Institution - 0159

Aarhus, Central Jutland, 8200, Denmark

NOT YET RECRUITING

Local Institution - 0182

Hovedvejen 19, Frederiksberg, 2000, Denmark

NOT YET RECRUITING

Local Institution - 0157

Glostrup, Region Sjælland, 2600, Denmark

NOT YET RECRUITING

Local Institution - 0158

Aalborg, 9000, Denmark

NOT YET RECRUITING

Local Institution - 0123

Warsaw, Masovian Voivodeship, 02-957, Poland

NOT YET RECRUITING

Local Institution - 0122

Bialystok, Podlaskie Voivodeship, 15-272, Poland

NOT YET RECRUITING

Local Institution - 0001

Poznan, 60-744, Poland

NOT YET RECRUITING

Local Institution - 0103

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0105

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0107

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0110

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0174

Bucharest, 011241, Romania

NOT YET RECRUITING

Local Institution - 0106

Bucharest, 41914, Romania

NOT YET RECRUITING

Local Institution - 0109

Bucharest, 41914, Romania

NOT YET RECRUITING

Local Institution - 0112

Barcelona, Barcelona [Barcelona], 08003, Spain

NOT YET RECRUITING

Local Institution - 0167

Valladolid, 47012, Spain

NOT YET RECRUITING

Local Institution - 0181

Zamora, 49021, Spain

NOT YET RECRUITING

Local Institution - 0094

Cambridge, CB21 5EF, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): March 3, 2029
• Study Completion (Estimated): March 3, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

BU (1); DK (4); GB (1); PL (3); CZ (2); ES (3); RO (7); US (34); AR (4)