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IMVT-1402

Clinical trials are investigating IMVT-1402 in people with generalized myasthenia gravis, from mild to severe disease. The main goal is to evaluate efficacy and safety, with a focus on changes in symptoms and daily function in antibody-positive participants.

Table of contents

Trial overview

The clinical trial NCT07039916 is studying IMVT-1402 in participants with generalized myasthenia gravis, from mild to severe disease.[1] It is an interventional study, which means researchers assign a treatment and then measure what happens.[1]

The study is in Phase 3 and is currently listed as Authorised.[1] Phase 3 trials usually include larger groups of people to better understand how a treatment performs in a real patient population.[1]

Who can join the study

The trial is designed for people with generalized myasthenia gravis, and it includes participants with mild to severe disease.[1] The main outcome is focused on antibody-positive participants, so this group is especially important in the study results.[1]

Antibody-positive means a blood test shows certain antibodies.[1] In this trial, that test result helps define the group in which the main symptom change is measured.[1]

What is being measured

The main primary outcome is the change from baseline in the MG-ADL score for antibody-positive participants.[1] Baseline means the starting point before treatment begins.[1]

MG-ADL is a score that looks at how myasthenia gravis affects daily activities.[1] A change in this score helps researchers see whether symptoms and day-to-day function improve or worsen during the study.[1]

How the study is designed

Participants may receive IMVT-1402 or placebo.[1] A placebo looks the same as the study treatment but has no active substance, which helps researchers compare results fairly.[1]

The listed intervention for IMVT-1402 is 600 mg given by subcutaneous administration.[1] Subcutaneous means under the skin.[1]

  • IMVT-1402 arm: participants receive the study drug as planned in the trial.[1]
  • Placebo arm: participants receive a look-alike treatment without active substance, so the study can compare outcomes.[1]

Trial status and size

The planned enrollment is 231 participants.[1] Enrollment means the number of people the study aims to include.[1]

Because this is a Phase 3 study, the results may help show whether IMVT-1402 can improve symptoms and daily function in people with generalized myasthenia gravis.[1] The key focus is on the change in MG-ADL score in antibody-positive participants.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07039916 Phase 3 Generalized Myasthenia Gravis Authorised 231

FAQ

  • What is being studied in the IMVT-1402 trial? The trial is studying whether IMVT-1402 can help people with generalized myasthenia gravis. It compares IMVT-1402 with placebo, which looks the same but has no active substance.
  • Who can take part in the study? The study is for participants with mild to severe generalized myasthenia gravis. The main outcome is measured in antibody-positive participants, so this group is especially important.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 studies are usually done in larger groups of people to better understand how well a treatment works and to continue checking safety.
  • What does the study measure? The main measure is the change from baseline in the MG-ADL score. This score checks how myasthenia gravis affects daily activities, such as speaking, chewing, swallowing, and breathing.
  • How many people are planned for the study? The planned enrollment is 231 participants. Enrollment means the number of people the study aims to include.

Sperimentazioni cliniche in corso su IMVT-1402

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Glossario

  • Generalized myasthenia gravis: A disease that causes muscle weakness in more than one part of the body. It can affect daily activities and, in some people, the muscles used for swallowing or breathing.
  • Mild to severe: This describes how serious the disease is. Mild means fewer symptoms, while severe means more symptoms or greater impact on daily life.
  • Antibody-positive: This means the blood test shows certain antibodies. Antibodies are proteins made by the immune system, and in this study they help define the group being measured.
  • Placebo: A placebo looks like the study treatment but has no active substance. It is used to compare results and see whether the study treatment works better.
  • Phase 3: A later stage of clinical research that usually includes more participants. It helps researchers learn more about how well a treatment works and whether it is safe.
  • Interventional study: A study where researchers give a treatment or compare treatments. This is different from an observational study, where no treatment is assigned.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: How well a treatment is tolerated and whether it causes unwanted problems.
  • MG-ADL score: A score that measures how myasthenia gravis affects daily activities. It helps show whether symptoms are getting better or worse.
  • Baseline: The starting point before treatment begins. Changes are measured against this first value.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sullefficacia-e-la-sicurezza-di-imvt-1402-in-pazienti-con-miastenia-gravis-generalizzata-da-lieve-a-grave/