SchizophreniaPhase 2NCT07288333
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
A Phase 2 study testing NBI-1117570 in people with Schizophrenia, run by Neurocrine Biosciences at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NBI-1117570
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 16 Feb 2026to Aug 2027
- Phase
- Phase 2
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 55 years of age
- Primary diagnosis of schizophrenia ≥1 year before screening.
- Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
- Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.
Who cannot join
- Considered to be at imminent risk of suicide or injury to self or others.
- History of epilepsy, seizures, or convulsions.
- Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.
- Currently taking prohibited medications.
- Pregnant or lactating.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Bulgaria3 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Kazanlak, 6100
- Recruiting
Neurocrine Clinical Site
Pazardzhik, 4400
- Recruiting
Neurocrine Clinical Site
Targovishte, 7700
United Kingdom2 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
London, SE5 8AZ
- Recruiting
Neurocrine Clinical Site
Oxford, OX3 7JX
Romania1 site, 1 recruiting
- Recruiting
Neurocrine Clinical Site
Târgu Mureş, 540136
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
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.
- Conditions
- Schizophrenia
- Being tested
- NBI-1117570, Placebo
- Keywords
- Schizophrenia, NBI-1117570
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117570Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| NBI-1117570: Lower-dose | Experimental | Participants will receive a lower-dose of NBI-1117570. Receives: Drug: NBI-1117570 |
| NBI-1117570: Higher-dose | Experimental | Participants will receive a higher-dose of NBI-1117570. Receives: Drug: NBI-1117570 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NBI-1117570. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Measured: Day 35
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Measured: Day 1 up to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start16 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT07288333
- Sponsor's protocol ID
- NBI-1117570-SCZ2035
- Other IDs
- 2025-521868-35-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No