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

Phase 3

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: NBI-1117568; Drug: Placebo

• Registration Number: NCT06963034
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 284

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5	Baseline, Week 5

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5	Baseline, Week 5