Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Key facts

Study ID

NCT07467993

Run by

Novartis Pharmaceuticals

People needed

142

Starts

2026-03-16

Expected to finish

2027-07-29

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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:
• i. Item 1 (P1; delusions)
• ii. Item 2 (P2; conceptual disorganization)
• iii. Item 3 (P3; hallucinatory behavior)
• iv. Item 6 (P6; suspiciousness/persecution)

You may not qualify if…

• 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

Where it is running

• Pillar Clinical Research LLC — Bentonville, Arkansas, United States (enrolling)
• CNRI Los Angeles LLC — Pico Rivera, California, United States (enrolling)
• Segal Institute for Clinical Research — Miami, Florida, United States (enrolling)
• CenExel iResearch — Decatur, Georgia, United States (enrolling)
• Uptown Research Institute LLC — Chicago, Illinois, United States (enrolling)
• Pillar Clinical Research LLC — Chicago, Illinois, United States (enrolling)
• Arch Clinical Trials LLC — St Louis, Missouri, United States (enrolling)
• Novartis Investigative Site — Sofia, BGR, Bulgaria (enrolling)
• Novartis Investigative Site — Haskovo, Bulgaria (enrolling)
• Novartis Investigative Site — Kazanlak, Bulgaria (enrolling)
• Novartis Investigative Site — Lovech, Bulgaria (enrolling)
• Novartis Investigative Site — Plovdiv, Bulgaria (enrolling)
• Novartis Investigative Site — Sliven, Bulgaria (enrolling)
• Novartis Investigative Site — Sofia, Bulgaria (enrolling)
• Novartis Investigative Site — Veliko Tarnovo, Bulgaria (enrolling)
• Novartis Investigative Site — Vratsa, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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