Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

June 30, 2026 updated by: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

472

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Local Institution - 0143
        • Contact:
          • Site 0143
      • Córdoba, Argentina, 5000
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Santiago del Estero, Argentina, 4200
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0175
        • Contact:
          • Site 0175
  • Bulgaria
      • Novi Iskar, Bulgaria, 1282
        • Local Institution - 0191
        • Contact:
          • Site 0191
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0162
        • Contact:
          • Site 0162
      • Klecany, Czechia, 25067
        • Local Institution - 0014
        • Contact:
          • Site 0014
  • Denmark
      • Aalborg, Denmark, 9000
        • Local Institution - 0158
        • Contact:
          • Site 0158
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Local Institution - 0159
        • Contact:
          • Site 0159
    • Frederiksberg
      • Hovedvejen 19, Frederiksberg, Denmark, 2000
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Region Sjælland
      • Glostrup, Region Sjælland, Denmark, 2600
        • Local Institution - 0157
        • Contact:
          • Site 0157
  • Poland
      • Poznan, Poland, 60-744
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-272
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Local Institution - 0120
        • Contact:
          • Site 0120
  • Romania
      • Bucharest, Romania, 011241
        • Local Institution - 0174
        • Contact:
          • Site 0174
      • Bucharest, Romania, 41914
        • Local Institution - 0106
        • Contact:
          • Site 0106
      • Bucharest, Romania, 41914
        • Local Institution - 0109
        • Contact:
          • Site 0109
      • Iași, Romania, 700282
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0105
        • Contact:
          • Site 0105
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0107
        • Contact:
          • Site 0107
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0110
        • Contact:
          • Site 0110
  • Spain
      • Valladolid, Spain, 47012
        • Local Institution - 0167
        • Contact:
          • Site 0167
      • Zamora, Spain, 49021
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0101
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Local Institution - 0177
        • Contact:
          • Site 0177
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Local Institution - 0133
        • Contact:
          • Site 0133
      • Bentonville, Arkansas, United States, 72712
        • Local Institution - 0154
        • Contact:
          • Site 0154
      • Little Rock, Arkansas, United States, 72204
        • Local Institution - 0139
        • Contact:
          • Site 0139
      • Little Rock, Arkansas, United States, 72211
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Rogers, Arkansas, United States, 72758
        • Local Institution - 0153
        • Contact:
          • Site 0153
    • California
      • Anaheim, California, United States, 92805
        • Local Institution - 0190
        • Contact:
          • Site 0190
      • Bellflower, California, United States, 90706
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Chino, California, United States, 91710
        • Local Institution - 0188
        • Contact:
          • Site 0188
      • Culver City, California, United States, 90230
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Garden Grove, California, United States, 92845
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • La Habra, California, United States, 90631
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Lemon Grove, California, United States, 91945
        • Local Institution - 0128
        • Contact:
          • Site 0128
      • Montclair, California, United States, 91763
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • Orange, California, United States, 92868
        • Local Institution - 0151
        • Contact:
          • Site 0151
      • Pico Rivera, California, United States, 90660
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Redlands, California, United States, 92373
        • Local Institution - 0185
        • Contact:
          • Site 0185
      • Riverside, California, United States, 92506
        • Local Institution - 0186
        • Contact:
          • Site 0186
    • Florida
      • Hollywood, Florida, United States, 33021
        • Local Institution - 0149
      • Hollywood, Florida, United States, 33024
        • Local Institution - 0145
        • Contact:
          • Site 0145
      • Miami, Florida, United States, 33135
        • Local Institution - 0075
      • Miami Lakes, Florida, United States, 33016
        • Local Institution - 0054
      • Miami Springs, Florida, United States, 33166
        • Local Institution - 0134
      • West Palm Beach, Florida, United States, 33407
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Local Institution - 0166
        • Contact:
          • Site 0166
      • Sandy Springs, Georgia, United States, 30328
        • Local Institution - 0070
        • Contact:
          • Site 0070
      • Savannah, Georgia, United States, 31405
        • Local Institution - 0189
        • Contact:
          • Site 0189
    • Illinois
      • Chicago, Illinois, United States, 60640-5017
        • Local Institution - 0067
        • Contact:
          • Site 0067
      • Chicago, Illinois, United States, 60641
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Local Institution - 0023
    • New York
      • Buffalo, New York, United States, 14215
        • Local Institution - 0135
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Texas
      • Austin, Texas, United States, 78754
        • Local Institution - 0049
        • Contact:
          • Site 0049

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: KarXT
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time From Randomization to the First Relapse Event
Time Frame: Up to approximately Week 43
Up to approximately Week 43

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Discontinuation During Double-blind Treatment Period
Time Frame: Approximately From Week 18 to 43
Approximately From Week 18 to 43
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Procholinergic Symptoms
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Anticholinergic Symptoms
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 3, 2026

Primary Completion (Estimated)

March 3, 2029

Study Completion (Estimated)

March 3, 2029

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0006
  • 2025-523664-20 (Other Identifier: EU CT Number)
  • U1111-1327-7599 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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