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
1 other identifier
interventional
560
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Dec 2025
Longer than P75 for phase_3 schizophrenia
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2025
CompletedFirst Posted
Study publicly available on registry
November 13, 2025
CompletedStudy Start
First participant enrolled
December 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
April 15, 2026
April 1, 2026
3.5 years
November 11, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From Randomization to Relapse
Up to approximately 30 weeks
Study Arms (2)
NBI-1117568
EXPERIMENTALAll 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
PLACEBO COMPARATORAll 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
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
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
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The initial Open-label Stabilization Period is open-label and non-randomized.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2025
First Posted
November 13, 2025
Study Start
December 16, 2025
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04