Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

May 22, 2026 updated by: Neurocrine Biosciences

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

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

  • Bulgaria
      • Kazanlak, Bulgaria, 6100
        • Recruiting
        • Neurocrine Clinical Site
      • Pazardzhik, Bulgaria, 4400
        • Recruiting
        • Neurocrine Clinical Site
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Neurocrine Clinical Site
  • United Kingdom
      • London, United Kingdom, SE5 8AZ
        • Recruiting
        • Neurocrine Clinical Site
      • Oxford, United Kingdom, OX3 7JX
        • 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

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 18 to 55 years of age
  • Primary diagnosis of schizophrenia ≥1 year before screening.
  • Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
  • Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.

Key Exclusion Criteria:

  • Considered to be at imminent risk of suicide or injury to self or others.
  • History of epilepsy, seizures, or convulsions.
  • Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.
  • Currently taking prohibited medications.
  • Pregnant or lactating.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

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-1117570: Lower-dose
Participants will receive a lower-dose of NBI-1117570.
Drug: NBI-1117570
Oral administration
Experimental: NBI-1117570: Higher-dose
Participants will receive a higher-dose of NBI-1117570.
Drug: NBI-1117570
Oral administration
Placebo Comparator: Placebo
Participants will receive placebo matched to NBI-1117570.
Drug: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Time Frame: Day 35
Day 35

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Time Frame: Day 1 up to Day 49
Day 1 up to Day 49

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)

February 16, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-1117570-SCZ2035
  • 2025-521868-35-00 (Ctis)

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

product manufactured in and exported from the U.S.

Yes

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.

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