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

Recruiting · NCT07467993 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals

Interventions studied

GXV813Placebo

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

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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)

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
ther protocol-defined inclusion/exclusion criteria may apply

16 locations listed across 6 US states.