Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Neurocrine Biosciences

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: NBI-1117568; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05545111

NBI-1117568-SCZ2028

Details and patient eligibility

About

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.

Enrollment: 210 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Completed informed consent.
• Subject has a primary diagnosis of schizophrenia.
• The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
• Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
• Subject 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:

• An unstable medical condition, chronic disease, or malignancy.
• Considered by the investigator to be at imminent risk of suicide or injury to self or others.
• Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
• Positive alcohol test or drug screen for disallowed substances.
• Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 5 patient groups, including a placebo group

Dose Level A

Experimental group

Description:

Participant administered Dose Level A (6 weeks)

Treatment:

Drug: NBI-1117568

Dose Level B

Experimental group

Description:

Participant administered Dose Level B (6 weeks)

Treatment:

Drug: NBI-1117568

Dose Level C

Experimental group

Description:

Participant administered Dose Level C (6 weeks)

Treatment:

Drug: NBI-1117568

Dose Level D

Experimental group

Description:

Participant administered Dose Level D (6 weeks)

Treatment:

Drug: NBI-1117568

Placebo Schedule

Placebo Comparator group

Description:

Participant administered placebo (6 weeks)

Treatment:

Drug: Placebo