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

Neurocrine Biosciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: NBI-1117568; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07227818

NBI-1117568-SCZ3031

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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560 participants in 2 patient groups, including a placebo group

NBI-1117568

Experimental group

Description:

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.

Treatment:

Drug: NBI-1117568

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: NBI-1117568