NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
1 other identifier
interventional
284
1 country
21
Brief Summary
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started May 2025
Typical duration for phase_3 schizophrenia
21 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
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 6, 2026
February 1, 2026
2.4 years
April 30, 2025
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Baseline, Week 5
Secondary Outcomes (1)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5
Baseline, Week 5
Study Arms (2)
NBI-1117568
EXPERIMENTALParticipants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
Interventions
NBI-1117568 will be administered per schedule specified in the arm description.
Eligibility Criteria
You may qualify if:
- Participant has a primary diagnosis of schizophrenia
- Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
- Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
- Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
You may not qualify if:
- Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
- Participant has an unstable or poorly controlled medical condition or chronic disease
- Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
- Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
- Participant has a positive alcohol test or drug screen for disallowed substances
- Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Neurocrine Clinical Site
Bryant, Arkansas, 72022, United States
Neurocrine Clinical Site
Little Rock, Arkansas, 72211, United States
Neurocrine Clinical Site
Anaheim, California, 92805, United States
Neurocrine Clinical Site
Pico Rivera, California, 90660, United States
Neurocrine Clinical Site
San Diego, California, 92123, United States
Neurocrine Clinical Site
Sherman Oaks, California, 91403, United States
Neurocrine Clinical Site
Torrance, California, 90504, United States
Neurocrine Clinical Site
Hollywood, Florida, 33024, United States
Neurocrine Clinical Site
Miami Lakes, Florida, 33016, United States
Neurocrine Clinical Site
Atlanta, Georgia, 30331, United States
Neurocrine Clinical Site
Decatur, Georgia, 30030, United States
Neurocrine Clinical Site
Snellville, Georgia, 30078, United States
Neurocrine Clinical Site
Chicago, Illinois, 60640, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877, United States
Neurocrine Clinical Site
Watertown, Massachusetts, 02472, United States
Neurocrine Clinical Site
Marlton, New Jersey, 08053, United States
Neurocrine Clinical Site
Staten Island, New York, 10314, United States
Neurocrine Clinical Site
The Bronx, New York, 10461, United States
Neurocrine Clinical Site
Austin, Texas, 78754, United States
Neurocrine Clinical Site
DeSoto, Texas, 75115, United States
Neurocrine Clinical Site
Houston, Texas, 77043, 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 8, 2025
Study Start
May 8, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share