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Recruiting NCT07467993

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

Phase II Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GXV813, Placebo.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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

Interventions

  • Drug GXV813
    GXV813 administered orally.
  • Drug Placebo
    Placebo administered orally.

Primary outcome measures

  • Change from baseline in Positive and Negative Symptom Scale (PANSS) total score [Time frame: Baseline, Week 6]
Secondary outcome measures (8)
  • Number of participants with AEs [Time frame: Baseline to 6 weeks]
  • Participant clinically significant response [Time frame: Baseline, week 6]
  • Change from baseline in PANSS positive sub-score [Time frame: Baseline, week 6]
  • Change from baseline in PANSS negative sub-score [Time frame: Baseline, week 6]
  • Change from baseline in Marder negative factor score [Time frame: Baseline, week 6]
  • Change from baseline in Clinical Global Impression- Severity (CGI-S) scale [Time frame: Baseline up to week 6]
  • Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC) [Time frame: Up to 6 weeks]
  • Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax) [Time frame: Up to 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Bulgaria · 9 centers
  • Novartis Investigative Site — Sofia
  • Novartis Investigative Site — Haskovo
  • Novartis Investigative Site — Kazanlak
  • Novartis Investigative Site — Lovech
  • Novartis Investigative Site — Plovdiv
  • Novartis Investigative Site — Sliven
  • Novartis Investigative Site — Sofia
  • Novartis Investigative Site — Veliko Tarnovo
  • … and 1 more center
United States · 7 centers
  • Pillar Clinical Research LLC — Bentonville
  • CNRI Los Angeles LLC — Pico Rivera
  • Segal Institute for Clinical Research — Miami
  • CenExel iResearch — Decatur
  • Uptown Research Institute LLC — Chicago
  • Pillar Clinical Research LLC — Chicago
  • Arch Clinical Trials LLC — St Louis

Identifiers

NCT: NCT07467993 · CGXV813B12201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗