Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

Neurocrine Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: NBI-1117570

Study type: Interventional

Funder types: Industry

Identifiers

NCT07288333

2025-521868-35-00 (EU Trial (CTIS) Number)

NBI-1117570-SCZ2035

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

NBI-1117570: Lower-dose

Experimental group

Description:

Participants will receive a lower-dose of NBI-1117570.

Treatment:

Drug: NBI-1117570

NBI-1117570: Higher-dose

Experimental group

Description:

Participants will receive a higher-dose of NBI-1117570.

Treatment:

Drug: NBI-1117570

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to NBI-1117570.

Treatment:

Drug: Placebo