Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia (STAR-1)

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

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: GXV813

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Recruiting
      • Pillar Clinical Research LLC
      • Principal Investigator: Leslie Smith
  • California
    • Pico Rivera, California, United States, 90660
      • Recruiting
      • CNRI Los Angeles LLC
      • Principal Investigator: Mohamed El-Gabalawy
  • Florida
    • Miami, Florida, United States, 33016
      • Recruiting
      • Segal Institute for Clinical Research
      • Principal Investigator: Rishi Kakar
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExel iResearch
      • Principal Investigator: Kimball Johnson
  • Illinois
    • Chicago, Illinois, United States, 60641
      • Recruiting
      • Pillar Clinical Research LLC
      • Principal Investigator: Scott Bartley
    • Chicago, Illinois, United States, 60640
      • Recruiting
      • Uptown Research Institute LLC
      • Principal Investigator: John Sonnenberg
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Arch Clinical Trials LLC
      • Principal Investigator: Syed Junaid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Placebo administered orally.
Experimental: GXV813; GXV813 administered orally.	Drug: GXV813; GXV813 administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	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.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; GVX813
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CGXV813B12201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No