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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07227818
- Acronym / sponsor ID
- NBI-1117568-SCZ3031
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, NBI-1117568
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI-1117568 | Experimental | Drug: NBI-1117568All 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. |
| Placebo | Placebo comparator | Drug: NBI-1117568, Drug: PlaceboAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-1117568Oral capsules | Drug | NBI-1117568, Placebo |
| PlaceboOral capsules | Drug | Placebo |
Primary outcome
Time From Randomization to Relapse
Time frame: Up to approximately 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Development Lead study director
Neurocrine Biosciences
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Serbia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurocrine Medical Information Call Center (1-877-641-3461, medinfo@neurocrine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Randomization to Relapse (time frame: Up to approximately 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.