Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

NCT07686263 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00062025-523664-20U1111-1327-7599
• Study Type: interventional
• Target: 472
• Locations: 9 countries
• Sites: 61

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 (61)

Local Institution - 0133

Bentonville, Arkansas, 72712, United States

Location

Local Institution - 0154

Bentonville, Arkansas, 72712, United States

Location

Local Institution - 0139

Little Rock, Arkansas, 72204, United States

Location

Local Institution - 0021

Little Rock, Arkansas, 72211, United States

Location

Local Institution - 0153

Rogers, Arkansas, 72758, United States

Location

Local Institution - 0190

Anaheim, California, 92805, United States

Location

Local Institution - 0040

Bellflower, California, 90706, United States

Location

Local Institution - 0188

Chino, California, 91710, United States

Location

Local Institution - 0032

Culver City, California, 90230, United States

Location

Local Institution - 0037

Garden Grove, California, 92845, United States

Location

Local Institution - 0068

La Habra, California, 90631, United States

Location

Local Institution - 0128

Lemon Grove, California, 91945, United States

Location

Local Institution - 0187

Montclair, California, 91763, United States

Location

Local Institution - 0151

Orange, California, 92868, United States

Location

Local Institution - 0030

Pico Rivera, California, 90660, United States

Location

Local Institution - 0185

Redlands, California, 92373, United States

Location

Local Institution - 0186

Riverside, California, 92506, United States

Location

Local Institution - 0149

Hollywood, Florida, 33021, United States

Location

Local Institution - 0145

Hollywood, Florida, 33024, United States

Location

Local Institution - 0075

Miami, Florida, 33135, United States

Location

Local Institution - 0054

Miami Lakes, Florida, 33016, United States

Location

Local Institution - 0134

Miami Springs, Florida, 33166, United States

Location

Local Institution - 0044

West Palm Beach, Florida, 33407, United States

Location

Local Institution - 0166

Atlanta, Georgia, 30331, United States

Location

Local Institution - 0070

Sandy Springs, Georgia, 30328, United States

Location

Local Institution - 0189

Savannah, Georgia, 31405, United States

Location

Local Institution - 0067

Chicago, Illinois, 60640-5017, United States

Location

Local Institution - 0056

Chicago, Illinois, 60641, United States

Location

Local Institution - 0023

St Louis, Missouri, 63141, United States

Location

Local Institution - 0135

Buffalo, New York, 14215, United States

Location

Local Institution - 0183

Cincinnati, Ohio, 45219, United States

Location

Local Institution - 0047

Oklahoma City, Oklahoma, 73112, United States

Location

Local Institution - 0049

Austin, Texas, 78754, United States

Location

Local Institution - 0175

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0143

Buenos Aires, C1199ABB, Argentina

Location

Local Institution - 0002

Córdoba, 5000, Argentina

Location

Local Institution - 0144

Santiago del Estero, 4200, Argentina

Location

Local Institution - 0191

Novi Iskar, 1282, Bulgaria

Location

Local Institution - 0162

Brno, 625 00, Czechia

Location

Local Institution - 0014

Klecany, 25067, Czechia

Location

Local Institution - 0159

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0182

Hovedvejen 19, Frederiksberg, 2000, Denmark

Location

Local Institution - 0157

Glostrup, Region Sjælland, 2600, Denmark

Location

Local Institution - 0158

Aalborg, 9000, Denmark

Location

Local Institution - 0123

Warsaw, Masovian Voivodeship, 02-957, Poland

Location

Local Institution - 0122

Bialystok, Podlaskie Voivodeship, 15-272, Poland

Location

Local Institution - 0120

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Local Institution - 0001

Poznan, 60-744, Poland

Location

Local Institution - 0103

Bucharest, Bucharest, 041914, Romania

Location

Local Institution - 0105

Bucharest, Bucharest, 041914, Romania

Location

Local Institution - 0107

Bucharest, Bucharest, 041914, Romania

Location

Local Institution - 0110

Bucharest, Bucharest, 041914, Romania

Location

Local Institution - 0174

Bucharest, 011241, Romania

Location

Local Institution - 0106

Bucharest, 41914, Romania

Location

Local Institution - 0109

Bucharest, 41914, Romania

Location

Local Institution - 0055

Iași, 700282, Romania

Location

Local Institution - 0112

Barcelona, Barcelona [Barcelona], 08003, Spain

Location

Local Institution - 0101

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0167

Valladolid, 47012, Spain

Location

Local Institution - 0181

Zamora, 49021, Spain

Location

Local Institution - 0177

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

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 (Estimated): September 3, 2026
• Primary Completion (Estimated): March 3, 2029
• Study Completion (Estimated): March 3, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06

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 (4); CZ (2); ES (4); RO (8); US (33); AR (4)