GXV813 for adults hospitalized with acute schizophrenia

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)

This trial will test whether the medication GXV813 helps adults hospitalized for an acute episode of schizophrenia and whether it is safe and well tolerated.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 7 sites (Bentonville, Arkansas and 6 other locations)
• Trial ID: NCT07467993 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo-controlled study enrolls adults hospitalized for an acute exacerbation of schizophrenia to receive either GXV813 or placebo. Eligible participants are 18–65 years old with DSM-5–confirmed schizophrenia who require inpatient care and can provide informed consent. Participants must be willing to remain confined to the inpatient setting for the treatment period while investigators monitor symptom change, safety, and tolerability. Primary outcomes focus on treatment response during the acute episode and the occurrence of adverse events; dosing details and total study duration are not provided in the public record.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with DSM-5–confirmed schizophrenia experiencing an acute relapse requiring hospitalization, able to consent, and willing to stay inpatient for the treatment period.

Not a fit: Patients who are stable outpatients, have psychotic disorders other than schizophrenia, are outside the 18–65 age range, or cannot consent are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GXV813 could provide a new treatment option that reduces acute psychotic symptoms and is tolerable for hospitalized patients.

How similar studies have performed: Other antipsychotic trials have shown benefit in acute hospitalized schizophrenia, but GXV813 appears to be a novel investigational compound with limited public efficacy data to date.

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

Where this trial is running

Bentonville, Arkansas and 6 other locations

• Pillar Clinical Research LLC — Bentonville, Arkansas, United States (Recruiting)
• CNRI Los Angeles LLC — Pico Rivera, California, United States (Recruiting)
• Segal Institute for Clinical Research — Miami, Florida, United States (Recruiting)
• CenExel iResearch — Decatur, Georgia, United States (Recruiting)
• Uptown Research Institute LLC — Chicago, Illinois, United States (Recruiting)
• Pillar Clinical Research LLC — Chicago, Illinois, United States (Recruiting)
• Arch Clinical Trials LLC — St Louis, Missouri, United States (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Schizophrenia; GVX813