SchizophreniaPhase 2STAR-1NCT07467993
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
A Phase 2 study testing GXV813 in people with Schizophrenia, run by Novartis Pharmaceuticals at 16 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- GXV813
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 16 Mar 2026to 29 Jul 2027
- Phase
- Phase 2
- 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 is aged 18 to 65 years, inclusive, at screening
- Participant is capable of providing informed consent
- Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
- Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
- Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms
Show all 12Show fewer
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
- Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- Item 6 (P6; suspiciousness/persecution)
Who cannot join
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
- History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
16 sites in 2 countries
Bulgaria9 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Haskovo, 6300
- Recruiting
Novartis Investigative Site
Kazanlak, 6100
- Recruiting
Novartis Investigative Site
Lovech, 5500
- Recruiting
Novartis Investigative Site
Plovdiv, 4002
- Recruiting
Novartis Investigative Site
Sliven, 8800
- Recruiting
Novartis Investigative Site
Sofia, BGR, 1431
- Recruiting
Novartis Investigative Site
Sofia, 1377
- Recruiting
Novartis Investigative Site
Veliko Tarnovo, 5000
- Recruiting
Novartis Investigative Site
Vratsa, 3000
United States7 sites, 7 recruiting
- Recruiting
Pillar Clinical Research LLC
Bentonville, Arkansas, 72712
501-307-1919
Leslie Smith
- Recruiting
Uptown Research Institute LLC
Chicago, Illinois, 60640
John Sonnenberg
- Recruiting
Pillar Clinical Research LLC
Chicago, Illinois, 60641
Scott Bartley
- Recruiting
CenExel iResearch
Decatur, Georgia, 30030
Kimball Johnson
- Recruiting
Segal Institute for Clinical Research
Miami, Florida, 33016
Rishi Kakar
- Recruiting
CNRI Los Angeles LLC
Pico Rivera, California, 90660
Mohamed El-Gabalawy
- Recruiting
Arch Clinical Trials LLC
St Louis, Missouri, 63141
Syed Junaid
About this study
Official title: A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
- Conditions
- Schizophrenia
- Being tested
- GXV813, Placebo
- Keywords
- Schizophrenia, GVX813
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GXV813Drug
GXV813 administered orally.
PlaceboDrug
Placebo administered orally.
| Study group | Role | What they receive |
|---|---|---|
| GXV813 | Experimental | GXV813 administered orally. Receives: Drug: GXV813 |
| Placebo | Placebo comparator | Placebo administered orally. 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 Symptom Scale (PANSS) total score
PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity.
Measured: Baseline, Week 6
Secondary outcomes (8)
Number of participants with AEs
Assessment of overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia. This includes monitoring the occurrence and severity of adverse events, results of clinical laboratory tests, changes in vital signs, ECG findings, physical examinations.
Measured: Baseline to 6 weeks
Participant clinically significant response
Proportion of participants achieving a clinically significant response, defined as a ≥30% improvement in PANSS total score or a 1-point improvement in Clinical Global Impression-Severity (CGI-S) score from baseline at week 6, comparing GXV813 to placebo.
Measured: Baseline, week 6
Change from baseline in PANSS positive sub-score
Assessment of the effect of GXV813 versus placebo on positive symptoms of schizophrenia, measured by the change from baseline in the PANSS positive sub-score at week 6., which measures symptoms that reflect an excess or distortion of normal mental functions. Each item is rated from 1 (absent) to 7 (extreme).
Measured: Baseline, week 6
Change from baseline in PANSS negative sub-score
Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the PANSS negative sub-score (this sub-score is calculated by summing the ratings of seven items, each scored from 1 (absent) to 7 (extreme)) at week 6.
Measured: Baseline, week 6
Change from baseline in Marder negative factor score
Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the Marder (it is a five-factor structure derived from factor analysis of PANSS data) negative factor score at week 6.
Measured: Baseline, week 6
Change from baseline in Clinical Global Impression- Severity (CGI-S) scale
Assessment of the effect of GXV813 versus placebo on overall illness severity, measured by the change from baseline in the CGI-S scale at week 6. The CGI-S scale uses a 7-point rating system, where the highest score indicates greather severity.
Measured: Baseline up to week 6
Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC)
The Area Under the Curve (AUC) in pharmacokinetics represents the total drug exposure over time. It is the area under the plot of drug concentration in plasma versus time following administration.
Measured: Up to 6 weeks
Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax)
Cmax is the highest concentration of a drug measured in plasma after administration and before the next dose.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Mar 2026
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jul 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 Novartis PharmaceuticalsThe 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
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467993
- Sponsor's protocol ID
- CGXV813B12201
- Acronym
- STAR-1
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)
- ClinicalTrials.gov ID
- NCT07467993
- Acronym / sponsor ID
- STAR-1 / CGXV813B12201
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, GVX813
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Jul 2027 (estimated)
- First posted
- 12 Mar 2026 (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 purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
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 |
|---|---|---|
| GXV813 | Experimental | Drug: GXV813GXV813 administered orally. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant is aged 18 to 65 years, inclusive, at screening
- Participant is capable of providing informed consent
- Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
- Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
- Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
Key exclusion criteria (5 listed)
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
- History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| GXV813GXV813 administered orally. | Drug | GXV813 |
| PlaceboPlacebo administered orally. | Drug | Placebo |
Primary outcome
Change from baseline in Positive and Negative Symptom Scale (PANSS) total score
Time frame: Baseline, Week 6
PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity.
8 secondary outcomes
Number of participants with AEs
Time frame: Baseline to 6 weeks
Participant clinically significant response
Time frame: Baseline, week 6
Change from baseline in PANSS positive sub-score
Time frame: Baseline, week 6
Change from baseline in PANSS negative sub-score
Time frame: Baseline, week 6
Change from baseline in Marder negative factor score
Time frame: Baseline, week 6
Change from baseline in Clinical Global Impression- Severity (CGI-S) scale
Time frame: Baseline up to week 6
Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC)
Time frame: Up to 6 weeks
Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax)
Time frame: Up to 6 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 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals contact
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GXV813 in people with Schizophrenia, run by Novartis Pharmaceuticals at 16 sites in 2 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 12 inclusion and 5 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Bulgaria, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Positive and Negative Symptom Scale (PANSS) total score (time frame: Baseline, Week 6). 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 29 Jul 2026.