Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

May 13, 2026 updated by: Neurocrine Biosciences

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Neurocrine Clinical Site
      • La Habra, California, United States, 90631
        • Recruiting
        • Neurocrine Clinical Site
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Neurocrine Clinical Site
      • Oceanside, California, United States, 92056
        • Recruiting
        • Neurocrine Clinical Site
      • West Hills, California, United States, 91307
        • Recruiting
        • Neurocrine Clinical Site
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Neurocrine Clinical Site
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33155
        • Recruiting
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Neurocrine Clinical Site
      • West Palm Beach, Florida, United States, 33024
        • Recruiting
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Neurocrine Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Recruiting
        • Neurocrine Clinical Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Neurocrine Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Recruiting
        • Neurocrine Clinical Site
      • New York, New York, United States, 10029
        • Recruiting
        • Neurocrine Clinical Site
      • New York, New York, United States, 10036
        • Recruiting
        • Neurocrine Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.
  • Participant had the initial diagnosis of schizophrenia ≥1 year before screening.
  • Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.

Key Exclusion Criteria:

  • Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological [including dementing illness, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.
  • Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.
  • Participant has a history of clozapine treatment for treatment-resistant psychosis.
  • Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.
  • Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-1117568
All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period.
Drug: NBI-1117568
Oral capsules
Placebo Comparator: Placebo
All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.
Drug: Placebo
Oral capsules
Drug: NBI-1117568
Oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time From Randomization to Relapse
Time Frame: Up to approximately 30 weeks
Up to approximately 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Actual)

November 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1117568-SCZ3031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe