Recruiting

Phase 3

NBI-1117568NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Sponsor:

Neurocrine Biosciences

Code:

NCT06963034

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NBI-1117568

Placebo

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT06963034

Start date

May 8, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1117568

Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.

placebo comparator: Placebo

Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.

Interventions

NBI-1117568

NBI-1117568 will be administered per schedule specified in the arm description.

Placebo

Placebo will be administered per schedule specified in the arm description.

Primary outcome measure

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5 [ Time Frame: Baseline, Week 5 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Neurocrine Clinical Site

Recruiting

Anaheim, California, United States, 92805

Neurocrine Clinical Site

Recruiting

Pico Rivera, California, United States, 90660

Neurocrine Clinical Site

Recruiting

San Diego, California, United States, 92123

Neurocrine Clinical Site

Recruiting

Sherman Oaks, California, United States, 91403

Neurocrine Clinical Site

Recruiting

Torrance, California, United States, 90504

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Miami Lakes, Florida, United States, 33016

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30331

Neurocrine Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Neurocrine Clinical Site

Recruiting

Snellville, Georgia, United States, 30078

Neurocrine Clinical Site

Recruiting

Chicago, Illinois, United States, 60640

Neurocrine Clinical Site

Recruiting

Gaithersburg, Maryland, United States, 20877

Neurocrine Clinical Site

Recruiting

Watertown, Massachusetts, United States, 02472

Neurocrine Clinical Site

Recruiting

Marlton, New Jersey, United States, 08053

Neurocrine Clinical Site

Recruiting

Staten Island, New York, United States, 10314

Neurocrine Clinical Site

Recruiting

The Bronx, New York, United States, 10461

Neurocrine Clinical Site

Recruiting

Austin, Texas, United States, 78754

Neurocrine Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77043

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Mar 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-03-06.