NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Last updated: May 13, 2026
Sponsor: Neurocrine Biosciences
Overall Status: Active - Recruiting

Phase

3

Condition

Psychosis

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

NBI-1117568

Placebo

Clinical Study ID

NCT07105098
NBI-1117568-SCZ3030
2025-521215-39-00
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has a primary diagnosis of schizophrenia

  • Participant is experiencing an acute exacerbation or relapse of symptoms andcurrently warrants hospitalization.

  • Participants taking prohibited medications, including antipsychotics, mustdiscontinue before study participation

  • Participant is willing and able to remain in an inpatient setting for the studyduration, follow instructions, and comply with the protocol requirements

Exclusion

Key Exclusion Criteria:

  • Participant has known hypersensitivity to any component of the formulation ofNBI-1117568

  • Participant has an unstable or poorly controlled medical condition or chronicdisease

  • Participant is considered by the investigator to be at imminent risk of suicide orinjury to self or others

  • Participant has a diagnosis of moderate or severe substance use disorder (with theexception 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 researchstudies and/or in the investigator's opinion, the participant is not capable ofadhering to the protocol requirements.

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

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: NBI-1117568
Phase: 3
Study Start date:
August 11, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Neurocrine Clinical Site

    Sliven, 8800
    Bulgaria

    Active - Recruiting

  • Neurocrine Clinical Site

    Veliko Tarnovo, 5047
    Bulgaria

    Site Not Available

  • Neurocrine Clinical Site

    Vratsa, 3001
    Bulgaria

    Active - Recruiting

  • Neurocrine Clinical Site

    Győr, 9024
    Hungary

    Active - Recruiting

  • Neurocrine Clinical Site

    Brasov, 507190
    Romania

    Active - Recruiting

  • Neurocrine Clinical Site

    Bucharest, 41914
    Romania

    Active - Recruiting

  • Neurocrine Clinical Site

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Neurocrine Clinical Site

    Gornja Toponica, 18202
    Serbia

    Active - Recruiting

  • Neurocrine Clinical Site

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Neurocrine Clinical Site

    Culver City, California 90230
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Riverside, California 92506
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Culver City 5341114, California 5332921 90230
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Garden Grove 5351515, California 5332921 92845
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Riverside 5387877, California 5332921 92506
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • Neurocrine Clinical Site

    North Canton, Ohio 44720
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    North Canton 5164706, Ohio 5165418 44720
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.