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

RecruitingPhase 3

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

Sponsor: Neurocrine Biosciences · Participants: 560 · Started: Dec 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07227818

Locations in the U.S.

CaliforniaNeurocrine Clinical Site, Garden Grove
Neurocrine Clinical Site, La Habra
Neurocrine Clinical Site, Lemon Grove
Neurocrine Clinical Site, Oceanside
Neurocrine Clinical Site, Torrance
FloridaNeurocrine Clinical Site, Hollywood
Neurocrine Clinical Site, Maitland
Neurocrine Clinical Site, Miami
Neurocrine Clinical Site, Miami
Neurocrine Clinical Site, Tampa
Neurocrine Clinical Site, West Palm Beach
GeorgiaNeurocrine Clinical Site, Atlanta
MassachusettsNeurocrine Clinical Site, Boston
MississippiNeurocrine Clinical Site, Flowood
New JerseyNeurocrine Clinical Site, Marlton
New YorkNeurocrine Clinical Site, Cedarhurst
Neurocrine Clinical Site, New York
Neurocrine Clinical Site, The Bronx
TexasNeurocrine Clinical Site, DeSoto
WashingtonNeurocrine Clinical Site, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.