A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Other: KarXT Matching Placebo; Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT07288567

2025-523711-11-00 (Other Identifier)

U1111-1325-9936 (Other Identifier)

CN012-0020

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Enrollment: 166 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
• PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
• Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).

Exclusion criteria

• Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
• History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
• All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
• Any neurological disorder, except for Tourette's Syndrome.
• Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

KarXT

Experimental group

Treatment:

Drug: KarXT

Placebo

Placebo Comparator group

Treatment:

Other: KarXT Matching Placebo