Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
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
2 other identifiers
interventional
120
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Feb 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedStudy Start
First participant enrolled
February 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 15, 2026
April 1, 2026
1.5 years
December 15, 2025
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Day 35
Secondary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Day 1 up to Day 49
Study Arms (3)
NBI-1117570: Lower-dose
EXPERIMENTALParticipants will receive a lower-dose of NBI-1117570.
NBI-1117570: Higher-dose
EXPERIMENTALParticipants will receive a higher-dose of NBI-1117570.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to NBI-1117570.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Neurocrine Clinical Site
London, SE5 8AZ, United Kingdom
Neurocrine Clinical Site
Oxford, OX3 7JX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2025
First Posted
December 17, 2025
Study Start
February 16, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share