Recruiting
Phase 3

NBI-1117568

Sponsor:

Neurocrine Biosciences

Code:

NCT07105098

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

NCT07105098

Start date

Aug 11, 2025

Status verified date

Apr, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

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
  • Participant has 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

877-641-3461medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Culver City, California, United States, 90230

Neurocrine Clinical Site

Recruiting

Garden Grove, California, United States, 92845

Neurocrine Clinical Site

Recruiting

Riverside, California, United States, 92506

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30328

Neurocrine Clinical Site

Recruiting

North Canton, Ohio, United States, 44720

More Information

Sponsor

Neurocrine Biosciences

Last update posted

May 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-05-15.