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NCT07227818PHASE3Recruiting

Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

Neurocrine Biosciences

Start Date

12/16/2025

Completion Date

7/1/2029

Summary

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Eligibility Criteria

Age Range: 18 years to 65 years

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. * Participant had the initial diagnosis of schizophrenia ≥1 year before screening. * Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose. Key Exclusion Criteria: * Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \[including dementing illness, myasthenia gravis\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1. * Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease. * Participant has a history of clozapine treatment for treatment-resistant psychosis. * Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening. * Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Interventions

DRUG

NBI-1117568

DRUG

Placebo

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Conditions

Schizophrenia

Locations

Neurocrine Clinical Site

Garden Grove, California 92845

United States

Neurocrine Clinical Site

La Habra, California 90631

United States

Neurocrine Clinical Site

Lemon Grove, California 91945

United States

Neurocrine Clinical Site

Oceanside, California 92056

United States

Neurocrine Clinical Site

Torrance, California 90504

United States

Neurocrine Clinical Site

West Hills, California 91307

United States

Neurocrine Clinical Site

Hollywood, Florida 33024

United States

Neurocrine Clinical Site

Maitland, Florida 32751

United States

Neurocrine Clinical Site

Miami, Florida 33122

United States

Neurocrine Clinical Site

Miami, Florida 33155

United States

Neurocrine Clinical Site

Tampa, Florida 33629

United States

Neurocrine Clinical Site

West Palm Beach, Florida 33024

United States

Neurocrine Clinical Site

Atlanta, Georgia 30318

United States

Neurocrine Clinical Site

Boston, Massachusetts 02116

United States

Neurocrine Clinical Site

Flowood, Mississippi 39232

United States

Neurocrine Clinical Site

Cedarhurst, New York 11516

United States

Neurocrine Clinical Site

New York, New York 10029

United States

Neurocrine Clinical Site

New York, New York 10036

United States

Neurocrine Clinical Site

The Bronx, New York 10461

United States

Neurocrine Clinical Site

Bellevue, Washington 98007

United States