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NCT Number: NCT07467993

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Kazanlak, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GXV813

Drug

GXV813 administered orally.

Placebo

Drug

Placebo administered orally.

Primary outcomes

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

    Time frame: Baseline, Week 6

    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.

Secondary outcomes

  1. Number of participants with AEs

    Time frame: Baseline to 6 weeks

    Assessment of overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia. This includes monitoring the occurrence and severity of adverse events, results of clinical laboratory tests, changes in vital signs, ECG findings, physical examinations.

  2. Participant clinically significant response

    Time frame: Baseline, week 6

    Proportion of participants achieving a clinically significant response, defined as a ≥30% improvement in PANSS total score or a 1-point improvement in Clinical Global Impression-Severity (CGI-S) score from baseline at week 6, comparing GXV813 to placebo.

  3. Change from baseline in PANSS positive sub-score

    Time frame: Baseline, week 6

    Assessment of the effect of GXV813 versus placebo on positive symptoms of schizophrenia, measured by the change from baseline in the PANSS positive sub-score at week 6., which measures symptoms that reflect an excess or distortion of normal mental functions. Each item is rated from 1 (absent) to 7 (extreme).

  4. Change from baseline in PANSS negative sub-score

    Time frame: Baseline, week 6

    Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the PANSS negative sub-score (this sub-score is calculated by summing the ratings of seven items, each scored from 1 (absent) to 7 (extreme)) at week 6.

  5. Change from baseline in Marder negative factor score

    Time frame: Baseline, week 6

    Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the Marder (it is a five-factor structure derived from factor analysis of PANSS data) negative factor score at week 6.

  6. Change from baseline in Clinical Global Impression- Severity (CGI-S) scale

    Time frame: Baseline up to week 6

    Assessment of the effect of GXV813 versus placebo on overall illness severity, measured by the change from baseline in the CGI-S scale at week 6. The CGI-S scale uses a 7-point rating system, where the highest score indicates greather severity.

  7. Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC)

    Time frame: Up to 6 weeks

    The Area Under the Curve (AUC) in pharmacokinetics represents the total drug exposure over time. It is the area under the plot of drug concentration in plasma versus time following administration.

  8. Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax)

    Time frame: Up to 6 weeks

    Cmax is the highest concentration of a drug measured in plasma after administration and before the next dose.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: STAR-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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