Recruiting
Phase 3

KarXT & KarX-EC

Sponsor:

Bristol-Myers Squibb

Code:

NCT07285798

Conditions

Irritability Associated With Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

KarXT

KarX-EC

KarXT + KarX-EC Matching Placebo

Study Details

Brief summary:

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Conditions

Irritability Associated With Autism Spectrum Disorder

Study ID

NCT07285798

Start date

Oct 6, 2026

Status verified date

Nov, 2026

Completion date

Aug 6, 2029

Anticipated

Primary completion date

Aug 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
  • Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Exclusion Criteria

  • Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
  • Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
  • Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
  • Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
  • Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT + KarX-EC Arm

experimental: Placebo

Interventions

KarXT

Specified dose on specified days

KarX-EC

Specified dose on specified days

KarXT + KarX-EC Matching Placebo

Specified dose on specified days

Primary outcome measure

  • Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [ Time Frame: Week 8 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Cortica - Glendale

Recruiting

Glendale, California, United States, 91203

Contacts

Kevin Shapiro, Site 0013

747-286-2600

Cortica - Marin

Recruiting

San Rafael, California, United States, 94903

Contacts

Elysa Marco, Site 0116

415-572-4514

EmVenio Research - Chicago

Recruiting

Chicago, Illinois, United States, 60622

Contacts

Mitchell Glaser, Site 0014

773-620-2995

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Autism Spectrum Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.