NCT07105098 NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
| NCT ID | NCT07105098 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Neurocrine Biosciences |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 284 participants in total. It began in 2025-08-11 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
Eligibility Criteria
Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568 * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07105098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07105098 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 284 participants.
Is NCT07105098 currently recruiting?
Yes, NCT07105098 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07105098 trial being conducted?
This trial is being conducted at Culver City, United States, Garden Grove, United States, Riverside, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT07105098 clinical trial?
NCT07105098 is sponsored by Neurocrine Biosciences. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 284 participants.
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