A Phase 3 Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-04-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-523711-11-00

WHO UTN

U1111-1325-9936

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine if KarXT is better than placebo (“dummy drug” with no medicine) in reducing the symptoms of schizophrenia in teenagers (13-17 years old)

Secondary objectives 1

1. To determine if KarXT is better than placebo (“dummy drug” with no medicine) in reducing the overall severity of schizophrenia in teenagers (13-17 years old)

Conditions and MedDRA coding

Schizophrenia

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000027-PIP00-79

Plan to share 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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Participants must be 13 to 17 years of age, inclusive, at the time of signing the ICF
2. Participants' legally acceptable representative (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines
3. Participants with diagnosis of schizophrenia as defined by the DSM-5-TR criteria and experiencing symptoms of psychosis during screening
4. IOCBP must have a negative highly sensitive serum pregnancy test at screening and a urine test within 24 hours prior to the start of study intervention
5. Participants must agree to follow instructions for highly effective method(s) of contraception as described in the protocol and included in the ICF
6. Participants in a stable living condition and are expected to remain at the same location for the duration of the trial

Exclusion criteria 10

1. Participants with any primary DSM-5-TR disorder diagnosis other than schizophrenia within 12 months before screening including, but not limited to moderate to severe alcohol use disorder, substance (other than nicotine or caffeine) use disorder, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and post-traumatic stress disorder
2. Participants with a history or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease
3. Participants with any neurological disorder, except for Tourette’s Syndrome
4. Participants with uncontrolled diabetes or clinically significant abnormal fasting blood glucose level at screening
5. Participants who have been diagnosed with epilepsy, or have a history of seizures, severe head trauma or stroke
6. Participants who have a significant risk of committing violent acts, serious self-harm, or attempting suicide
7. Participants with prior exposure to KarXT(xanomeline-trospiumchloride)
8. Participants who experienced any adverse effects due to xanomeline or trospiumchloride
9. Participants with any clinically significant abnormal laboratory test results at Visit 1 (screening) as per investigator discretion
10. Participants who are showing inability to tolerate oral medication or swallow capsules

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5

Secondary endpoints 1

1. Change from baseline in Clinical Global Impression -Severity (CGI-S) score at Week 5

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 7

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications