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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: NBI-1117568; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Neurocrine Clinical Site
    • Rogers, Arkansas, United States, 72758
      • Neurocrine Clinical Site
  • California
    • Lemon Grove, California, United States, 91945
      • Neurocrine Clinical Site
    • Pico Rivera, California, United States, 90660
      • Neurocrine Clinical Site
    • San Diego, California, United States, 92123
      • Neurocrine Clinical Site
    • Torrance, California, United States, 90502
      • Neurocrine Clinical Site
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Neurocrine Clinical Site
    • Oakland Park, Florida, United States, 33334
      • Neurocrine Clinical Site
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Neurocrine Clinical Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Neurocrine Clinical Site
  • New Jersey
    • Berlin, New Jersey, United States, 08053
      • Neurocrine Clinical Site
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Neurocrine Clinical Site
  • Texas
    • Austin, Texas, United States, 78754
      • Neurocrine Clinical Site
    • DeSoto, Texas, United States, 75115
      • Neurocrine Clinical Site
    • Richardson, Texas, United States, 75080
      • Neurocrine Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level A; Participant administered Dose Level A (6 weeks)	Drug: NBI-1117568; Active treatment with orally administered NBI-1117568
Experimental: Dose Level B; Participant administered Dose Level B (6 weeks)	Drug: NBI-1117568; Active treatment with orally administered NBI-1117568
Experimental: Dose Level C; Participant administered Dose Level C (6 weeks)	Drug: NBI-1117568; Active treatment with orally administered NBI-1117568
Experimental: Dose Level D; Participant administered Dose Level D (6 weeks)	Drug: NBI-1117568; Active treatment with orally administered NBI-1117568
Placebo Comparator: Placebo Schedule; Participant administered placebo (6 weeks)	Drug: Placebo; Placebo matching NBI-1117568

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6	The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.	Baseline and Week 6

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences
• Investigators: Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia; NBI-1117568; muscarinic
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: NBI-1117568-SCZ2028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No