Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

NCT07288333 — Phase 2, Recruiting, 120 participants, Neurocrine Biosciences

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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

Registry	NCT07288333
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	120 (Estimated)
Sponsor	Neurocrine Biosciences (Industry)
Conditions	Schizophrenia
Interventions	NBI-1117570, Placebo (Drug)
Dates	start 2026-02-16, primary completion 2027-08-01 (estimated), completion 2027-08-01 (estimated), first posted 2025-12-17, last updated 2026-07-22
Locations	6 sites in Bulgaria, Romania, United Kingdom

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
NBI-1117570: Lower-dose	Experimental	Drug: NBI-1117570	Participants will receive a lower-dose of NBI-1117570.
NBI-1117570: Higher-dose	Experimental	Drug: NBI-1117570	Participants will receive a higher-dose of NBI-1117570.
Placebo	Placebo comparator	Drug: Placebo	Participants will receive placebo matched to NBI-1117570.

NBI-1117570 (Drug): Oral administration
Placebo (Drug): Oral administration

+Outcome measures

Primary outcomes

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35 [Day 35]

Secondary outcomes

Number of Participants With Treatment-emergent Adverse Event (TEAEs) [Day 1 up to Day 49]

+Eligibility

Sex: All, ages: 18 Years to 55 Years

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.

+Locations (6)

Facility	City	Country	Status
Neurocrine Clinical Site	Kazanlak	Bulgaria	Recruiting
Neurocrine Clinical Site	Pazardzhik	Bulgaria	Recruiting
Neurocrine Clinical Site	Targovishte	Bulgaria	Recruiting
Neurocrine Clinical Site	Târgu Mureş	Romania	Recruiting
Neurocrine Clinical Site	London	United Kingdom	Recruiting
Neurocrine Clinical Site	Oxford	United Kingdom	Recruiting

+Investigators

Clinical Development Lead, Study director, Neurocrine Biosciences

+Funding

NIH grants: 2025