Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia

Sponsor
Neurocrine Biosciences
Study ID
NCT07288333
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NBI-1117570 — DRUG
    Oral administration
  • Placebo — DRUG
    Oral administration

Study Details

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.

Key Dates

First listed
Dec 17, 2025
Start date
Feb 16, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

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