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

NCT07467993 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CGXV813B12201
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Schizophrenia

Keywords

Schizophrenia; GVX813

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of participants with AEs

  Baseline to 6 weeks

• Participant clinically significant response

  Baseline, week 6

• Change from baseline in PANSS positive sub-score

  Baseline, week 6

• Change from baseline in PANSS negative sub-score

  Baseline, week 6

• Change from baseline in Marder negative factor score

  Baseline, week 6

Study Arms (2)

GXV813

EXPERIMENTAL

GXV813 administered orally.

Drug: GXV813

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

GXV813 DRUG

GXV813 administered orally.

GXV813

Placebo DRUG

Placebo administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Pillar Clinical Research LLC

Bentonville, Arkansas, 72712, United States

RECRUITING

CNRI Los Angeles LLC

Pico Rivera, California, 90660, United States

RECRUITING

Segal Institute for Clinical Research

Miami, Florida, 33016, United States

RECRUITING

CenExel iResearch

Decatur, Georgia, 30030, United States

RECRUITING

Uptown Research Institute LLC

Chicago, Illinois, 60640, United States

RECRUITING

Pillar Clinical Research LLC

Chicago, Illinois, 60641, United States

RECRUITING

Arch Clinical Trials LLC

St Louis, Missouri, 63141, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)