AuthorisedTherapeutic exploratory (Phase II)Interventional

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)

This research study, called STAR-1, is looking into a new medicine named GXV813 for adults who are in hospital because of schizophrenia. The main goal is to find out if GXV813 is safe and well-tolerated by patients, and how effectively it helps reduce symptoms after six weeks of treatment, compared to a placebo (a dummy pill with no active medicine). Participants will be randomly assigned to receive either GXV813 or the placebo, and neither they nor their doctors will know which treatment they are getting. This is an early phase study (Phase 2a), meaning it's one of the first times this medicine is being tested in a larger group of patients, to see if it shows promise before moving on to bigger studies.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

29 Apr 2026

Schizophrenia

What is this study about?

This research study is focused on people who are in hospital because of schizophrenia. Schizophrenia is a long-term mental health condition that can cause a range of different symptoms, including changes in thoughts, feelings, and behaviour. The aim of this study is to explore a new potential medicine, called GXV813, to see if it could be a helpful treatment for these symptoms.

The study leaders want to understand a few key things: first, is GXV813 safe for patients? This means checking for any unwanted side effects and how well people can stick with the treatment. Second, they want to see if GXV813 actually helps to reduce the symptoms of schizophrenia. They'll be carefully measuring changes in symptoms over six weeks to see if people feel better.

This kind of study is called a 'Phase 2a' trial. This means it's an important early step in developing a new medicine. It's designed to get a better understanding of how the medicine works in people, what dose might be best, and if it's worth continuing with larger, more extensive studies. The results of this study will help guide whether GXV813 has potential to become a new treatment option for schizophrenia in the future.

Key takeaways

This study is testing a new medicine (GXV813) for hospitalized adults with schizophrenia.
It aims to check the medicine's safety, how well it's tolerated, and if it helps with symptoms.
Participants will receive either GXV813 or a dummy pill (placebo); neither they nor their doctors will know which.
The main treatment period lasts six weeks, with regular health checks throughout.
This is an early-stage study to see if the medicine holds promise for further development.

Who may be eligible?

This study is for adults aged 18 and over, of any gender, who have been diagnosed with schizophrenia according to specific medical guidelines (called DSM-5). You must currently be in hospital for your schizophrenia to be considered for this study.

The research team will have a detailed list of other health conditions, medications, and circumstances that might mean you cannot join. These rules are in place to make sure the study is as safe as possible for everyone involved and that the results they get are clear and reliable.

It's important to understand that even if you meet the main age, gender, and diagnosis criteria, the study doctors will need to review your full medical history to confirm if you are suitable for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with schizophrenia as per medical guidelines (DSM-5)?
Are you currently in hospital for your schizophrenia?
Are you able to attend regular appointments and assessments?
Are you willing to consider taking a new, experimental medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If you do, you would be randomly assigned to one of two groups: one group would receive the new medicine, GXV813, and the other would receive a placebo, which is a 'dummy pill' that looks like the active medicine but has no active ingredients. Neither you nor your study doctor would know which you are receiving, which helps make the study fair and unbiased.

Throughout the study, you would have several visits where the study team would regularly check your health. This would include physical examinations, blood tests, checks of your heart's electrical activity (ECG), and careful monitoring of your symptoms using specific questionnaires and assessments. They would be looking out for any side effects and seeing how your symptoms change over time. The main treatment part of the study would last for six weeks, with follow-up appointments to ensure your well-being. The total duration of your involvement, including screening and follow-up, would be made clear to you.

Potential risks and benefits

By taking part, you might benefit from close medical attention and potentially receive a new medicine that could help relieve your symptoms of schizophrenia, although there's also a chance you could receive a placebo. There might be risks associated with any new medicine, including unknown side effects, or feeling no benefit from the treatment. All possible side effects will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Bulgaria

Common questions

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to fairly compare the new medicine's effects.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving GXV813 or the placebo. This helps ensure the study results are as accurate as possible.

What does 'schizophrenia' mean in this study?

In this study, 'schizophrenia' refers to the diagnosis made using specific guidelines outlined in the DSM-5, which is a standard manual used by mental health professionals.

How long will I be in the study?

The main treatment period is planned for six weeks. Your overall involvement, including checks before and after treatment, will be explained in detail by the study team.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.