Last Update: Jul 29, 2026 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 Identifier: [NCT07467993](https://clinicaltrials.gov/ct2/show/NCT07467993) Novartis Reference Number:CGXV813B12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia Condition Schizophrenia Phase Phase2 Overall Status Recruiting Number of Participants142 Start Date Mar 16, 2026 Completion Date Jul 29, 2027 Gender All Age(s) 18 Years - 65 Years (Adult, Older Adult) ## Interventions Drug ### GXV813 GXV813 administered orally. Drug ### Placebo Placebo administered orally. ## Eligibility Criteria Inclusion Criteria: 1\. Participant is aged 18 to 65 years, inclusive, at screening 2\. Participant is capable of providing informed consent 3\. 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) 4\. 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 5\. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening 6\. 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: i. Item 1 (P1; delusions) ii. Item 2 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution) Exclusion Criteria: 1\. 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) 2\. 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 3\. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded 4\. 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 Bulgaria #### Novartis Investigative Site Recruiting Lovech,5500,Bulgaria #### Novartis Investigative Site Recruiting Sliven,8800,Bulgaria #### Novartis Investigative Site Recruiting Plovdiv,4002,Bulgaria #### Novartis Investigative Site Recruiting Kazanlak,6100,Bulgaria #### Novartis Investigative Site Recruiting Haskovo,6300,Bulgaria #### Novartis Investigative Site Recruiting Sofia,BGR,1431,Bulgaria #### Novartis Investigative Site Recruiting Vratsa,3000,Bulgaria #### Novartis Investigative Site Recruiting Veliko Tarnovo,5000,Bulgaria #### Novartis Investigative Site Recruiting Sofia,1377,Bulgaria United States #### Uptown Research Institute LLC Recruiting Chicago,Illinois,60640,United States ###### John Sonnenberg #### Pillar Clinical Research LLC Recruiting Chicago,Illinois,60641,United States ###### Scott Bartley #### CenExel iResearch Recruiting Decatur,Georgia,30030,United States ###### Kimball Johnson #### Segal Institute for Clinical Research Recruiting Miami,Florida,33016,United States ###### Rishi Kakar #### CNRI Los Angeles LLC Recruiting Pico Rivera,California,90660,United States ###### Mohamed El-Gabalawy #### Pillar Clinical Research LLC Recruiting Bentonville,Arkansas,72712,United States ###### Leslie Smith Phone: [501-307-1919](tel:501-307-1919) #### Arch Clinical Trials LLC Recruiting St Louis,Missouri,63141,United States ###### Syed Junaid ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: