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NBI-1117568 to prevent 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

Phase 3 Interventional Neurocrine Biosciences · NCT07227818

This will test whether continuing NBI-1117568 helps prevent symptom relapse in adults with schizophrenia who showed a stable response during an initial open-label treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment560 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations17 sites (Garden Grove, California and 16 other locations)
Trial IDNCT07227818 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study gives adults with schizophrenia an open-label course of NBI-1117568 and then compares continued NBI-1117568 with placebo to measure time to relapse. Adults who show a stable response during the open-label period are randomized into a placebo-controlled continuation phase to see if ongoing treatment delays symptom return. Key inclusion criteria include a DSM-5-TR diagnosis of schizophrenia for at least one year and prior positive response to at least one antipsychotic (excluding clozapine), while participants with unstable medical conditions or significant laboratory abnormalities are excluded. The trial is conducted at Neurocrine Clinical Sites in Southern California and tracks relapse rates and safety during the randomized phase.

Who should consider this trial

Good fit: Ideal candidates are adults with a DSM-5-TR diagnosis of schizophrenia for at least one year who achieve a stable response during open-label NBI-1117568 and do not require clozapine.

Not a fit: Patients with unstable or poorly controlled medical conditions, significant laboratory abnormalities, recent malignancy, or those who do not respond to the initial open-label NBI-1117568 are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, it could provide a new maintenance option that reduces the risk of relapse for adults with schizophrenia who respond to NBI-1117568.

How similar studies have performed: Relapse-prevention trials of other antipsychotics have shown benefit for some drugs, but NBI-1117568 itself is a newer agent and has not yet been proven in phase 3 for relapse prevention.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Garden Grove, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SchizophreniaNBI-1117568
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.