Recruiting

Phase 3

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

Sponsor:

Neurocrine Biosciences

Code:

NCT07227818

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NBI-1117568

Placebo

Study Details

Brief 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.

Conditions

Schizophrenia

Study ID

NCT07227818

Start date

Dec 16, 2025

Status verified date

Apr, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

560 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1117568

All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.

placebo comparator: Placebo

All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.

Interventions

NBI-1117568

Oral capsules

Placebo

Oral capsules

Primary outcome measure

Time From Randomization to Relapse [ Time Frame: Up to approximately 30 weeks ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Garden Grove, California, United States, 92845

Neurocrine Clinical Site

Recruiting

La Habra, California, United States, 90631

Neurocrine Clinical Site

Recruiting

Lemon Grove, California, United States, 91945

Neurocrine Clinical Site

Recruiting

Oceanside, California, United States, 92056

Neurocrine Clinical Site

Recruiting

Torrance, California, United States, 90504

Neurocrine Clinical Site

Recruiting

West Hills, California, United States, 91307

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Maitland, Florida, United States, 32751

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33122

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33155

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33629

Neurocrine Clinical Site

Recruiting

West Palm Beach, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30318

Neurocrine Clinical Site

Recruiting

Boston, Massachusetts, United States, 02116

Neurocrine Clinical Site

Recruiting

Flowood, Mississippi, United States, 39232

Neurocrine Clinical Site

Recruiting

Cedarhurst, New York, United States, 11516

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10029

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10036

Neurocrine Clinical Site

Recruiting

The Bronx, New York, United States, 10461

Neurocrine Clinical Site

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jun 5, 2026

Last verified

Apr, 2026

Keywords

Schizophrenia
NBI-1117568

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-06-05.