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Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- NBI-1117568 (drug)
- Placebo (drug)
Sponsor: Neurocrine Biosciences · Participants: 560 · Started: Dec 16, 2025
Contact the study team
- Neurocrine Medical Information Call Center · Phone: 1-877-641-3461
Official record on ClinicalTrials.gov — NCT07227818
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.