SchizophreniaPhase 3NCT07227818
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
A Phase 3 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 25 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NBI-1117568
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 16 Dec 2025to Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
United States22 sites, 20 recruiting
- Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, 30318
- Recruiting
Neurocrine Clinical Site
Bellevue, Washington, 98007
- Recruiting
Neurocrine Clinical Site
Boston, Massachusetts, 02116
- Recruiting
Neurocrine Clinical Site
Cedarhurst, New York, 11516
- Recruiting
Neurocrine Clinical Site
DeSoto, Texas, 75115
- Recruiting
Neurocrine Clinical Site
Flowood, Mississippi, 39232
- Recruiting
Neurocrine Clinical Site
Garden Grove, California, 92845
- Recruiting
Neurocrine Clinical Site
Hollywood, Florida, 33024
- Recruiting
Neurocrine Clinical Site
La Habra, California, 90631
- Recruiting
Neurocrine Clinical Site
Lemon Grove, California, 91945
- Recruiting
Neurocrine Clinical Site
Maitland, Florida, 32751
- Recruiting
Neurocrine Clinical Site
Marlton, New Jersey, 08054
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33122
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33155
- Recruiting
Neurocrine Clinical Site
New York, New York, 10029
- Withdrawn
Neurocrine Clinical Site
New York, New York, 10032
- Recruiting
Neurocrine Clinical Site
Oceanside, California, 92056
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33629
- Recruiting
Neurocrine Clinical Site
The Bronx, New York, 10461
- Recruiting
Neurocrine Clinical Site
Torrance, California, 90504
- Completed
Neurocrine Clinical Site
West Hills, California, 91307
- Recruiting
Neurocrine Clinical Site
West Palm Beach, Florida, 33024
Serbia2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Gornja Toponica, 18202
- Recruiting
Neurocrine Clinical Site
Kragujevac, 34000
Puerto Rico1 site, 1 recruiting
- Recruiting
Neurocrine Clinical Site
San Juan, 00918
About this study
Official title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- NBI-1117568, Placebo
- Keywords
- Schizophrenia, NBI-1117568
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117568Drug
Oral capsules
PlaceboDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| NBI-1117568 | Experimental | 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. Receives: Drug: NBI-1117568 |
| Placebo | Placebo comparator | 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. Receives: Drug: NBI-1117568; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Randomization to Relapse
Measured: Up to approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start16 Dec 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227818
- Sponsor's protocol ID
- NBI-1117568-SCZ3031
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No