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NCT07105098PHASE3Recruiting

NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Neurocrine Biosciences

Start Date

8/11/2025

Completion Date

11/1/2027

Summary

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

Eligibility Criteria

Age Range: 18 years to 65 years

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568 * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply.

Interventions

DRUG

NBI-1117568

DRUG

Placebo

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Conditions

Schizophrenia

Locations

Neurocrine Clinical Site

Culver City, California 90230

United States

Neurocrine Clinical Site

Garden Grove, California 92845

United States

Neurocrine Clinical Site

Riverside, California 92506

United States

Neurocrine Clinical Site

Atlanta, Georgia 30328

United States

Neurocrine Clinical Site

North Canton, Ohio 44720

United States

Neurocrine Clinical Site

Sliven, 8800

Bulgaria

Neurocrine Clinical Site

Veliko Tarnovo, 5047

Bulgaria

Neurocrine Clinical Site

Vratsa, 3001

Bulgaria

Neurocrine Clinical Site

Győr, 9024

Hungary

Neurocrine Clinical Site

Brasov, 500123

Romania

Neurocrine Clinical Site

Brasov, 507190

Romania

Neurocrine Clinical Site

Bucharest, 41914

Romania

Neurocrine Clinical Site

Belgrade, 11000

Serbia

Neurocrine Clinical Site

Gornja Toponica, 18202

Serbia

Neurocrine Clinical Site

Kragujevac, 34000

Serbia