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

Neurocrine Biosciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: NBI-1117568

Study type: Interventional

Funder types: Industry

Identifiers

NCT06963034

NBI-1117568-SCZ3029

Details and patient eligibility

About

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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups, including a placebo group

NBI-1117568

Experimental group

Description:

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

Treatment:

Drug: NBI-1117568

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo