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NCT Number: NCT07105098

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

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.

Recruiting

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocrine Clinical Site, Sliven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBI-1117568

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

    Time frame: Baseline, Week 5

Secondary outcomes

  1. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5

    Time frame: Baseline, Week 5

Study contacts

Contact information is provided by the study sponsor or research team.

Neurocrine Medical Information Call Center

CONTACT

[email protected]

877-641-3461

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Global, 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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