RecruitingPhase 2

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

United States142 participantsStarted 2026-03-16

Plain-language summary

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 range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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

Change from baseline in Positive and Negative Symptom Scale (PANSS) total score

Timeframe: Baseline, Week 6

NCT IDNCT07467993

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-22

Novartis Pharmaceuticals

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:

✕. 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