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GRISNILIMAB SETARITOX

Clinical trials investigating GRISNILIMAB SETARITOX are studying its use in early diffuse cutaneous systemic sclerosis, a serious form of autoimmune disease that affects the skin and sometimes internal organs. The trial data focus on safety in a small group of patients and measure harmful events during and after treatment.

Table of Contents

Trial overview

The available study for GRISNILIMAB SETARITOX is an interventional trial in early diffuse cutaneous systemic sclerosis (dcSSc).[1] The trial is authorised and includes 13 participants.[1]

The study title is T-Guard in dcSSc, and the intervention is listed as T-Guard given by intravenous infusion.[1]

Who is being studied

This trial is focused on people with early dcSSc, which is a form of systemic sclerosis that mainly affects the skin and can also involve other organs.[1] The source data do not list broader age groups, sex groups, or other eligibility details.[1]

Because the study is small, it is designed to give an early look at safety in a limited group of patients rather than to answer all questions about long-term benefit.[1]

Trial design and phase

This is a Phase 1 study, which means it is an early clinical trial stage that usually focuses on safety first.[1] It is also described as an interventional study, meaning participants receive the study treatment and researchers observe what happens.[1]

The treatment is given by intravenous infusion, which means it is delivered through a vein.[1]

What the study measures

The main endpoint is the incidence of Grade 3 or higher adverse events using CTCAE v5.[1] An adverse event is any medical problem that happens during the study, and Grade 3 or higher means a serious level on the trial safety scale.[1]

The safety window starts with the first infusion and continues until 28 days after the last T-Guard administration.[1] This helps researchers see whether serious problems happen during treatment or shortly after it ends.[1]

What this means for patients

For patients, this trial is mainly about learning whether the study treatment can be given safely in early dcSSc.[1] The study does not provide full proof of benefit, because the source data only describe a safety goal in a small Phase 1 group.[1]

Since the trial is authorised and already enrolled 13 participants, it shows active clinical research in a specific patient group with a clear safety focus.[1]

Trial ID Phase Condition studied Status Enrollment
2024-517283-28-00 Phase 1 Diffuse cutaneous systemic sclerosis Authorised 13

FAQ

  • What condition is being studied in the GRISNILIMAB SETARITOX trial? The trial is studying diffuse cutaneous systemic sclerosis, often called dcSSc. This is a form of systemic sclerosis that causes skin thickening and can affect other organs.
  • Who can take part in the trial? The study includes patients with early diffuse cutaneous systemic sclerosis. The trial enrolled 13 study participants.
  • What phase is the GRISNILIMAB SETARITOX trial? This is a Phase 1 trial. Phase 1 studies usually look first at safety and early signs of how a treatment performs.
  • What is the main goal of the trial? The main goal is to evaluate safety. The study looks at the number of serious side effects, especially Grade 3 or higher adverse events.
  • What does the trial measure? The trial measures Grade 3 or higher adverse events using CTCAE v5. It checks events from the first infusion until 28 days after the last dose.

Ongoing Clinical Trials on GRISNILIMAB SETARITOX

  • Study on the Safety of T-Guard (Dafsolimab Setaritox, Grisnilimab Setaritox) for Patients with Early Diffuse Cutaneous Systemic Sclerosis

    Recruiting

    1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Diffuse cutaneous systemic sclerosis (dcSSc): A type of systemic sclerosis that causes widespread skin thickening and may also affect internal organs.
  • Early disease: A stage where the illness has started recently or is still in an early phase.
  • Phase 1: The first stage of clinical testing, usually focused on safety.
  • Interventional study: A study where participants receive a treatment and researchers measure what happens.
  • Enrolled participants: The people who joined the study.
  • Adverse event (AE): A medical problem that happens during a study, whether or not it is caused by the treatment.
  • Grade 3 or higher: A serious level of side effect or medical problem, based on a standard rating system.
  • CTCAE v5: A standard medical scale used to classify and grade side effects in clinical trials.
  • Intravenous infusion: A treatment given through a vein, usually by a drip.
  • Safety endpoint: The main result researchers use to see if a treatment can be given safely.