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IMVT-1402

Clinical trials are studying IMVT-1402 in people with mild to severe generalized myasthenia gravis. These trials are designed to assess safety and efficacy, including changes in daily function and symptoms in antibody-positive participants.

Table of Contents

Trial overview

The clinical trial listed for IMVT-1402 is studying people with generalized myasthenia gravis, a disease that causes muscle weakness in more than one part of the body.[1]

This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes between groups.[1]

The trial is in Phase 3 and is currently marked as Authorised.[1]

Who is being studied

The study includes participants with mild to severe generalized myasthenia gravis.[1]

The main outcome is focused on antibody-positive participants, meaning people whose blood tests show certain antibodies linked to the condition.[1]

The planned enrollment is 231 participants.[1]

Study design and treatment groups

The trial compares IMVT-1402 with placebo, which is a look-alike treatment with no active substance.[1]

IMVT-1402 is given subcutaneously, meaning under the skin.[1]

The study title says it is designed to assess both efficacy and safety, so researchers want to see whether the treatment helps and how well it is tolerated.[1]

What the trial measures

The main outcome is the change from baseline in MG-ADL score for antibody-positive participants.[1]

Baseline means the starting point before treatment begins.[1]

MG-ADL stands for Myasthenia Gravis Activities of Daily Living, a score that shows how much the disease affects everyday tasks such as speaking, chewing, swallowing, and breathing.[1]

Why this trial matters

For people living with generalized myasthenia gravis, daily symptoms can affect simple tasks and quality of life.[1]

This Phase 3 trial is important because it looks at a larger group of participants and measures a practical outcome related to daily function.[1]

By comparing IMVT-1402 with placebo, the study aims to show whether the treatment offers a real benefit in antibody-positive people with this condition.[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 trials? The trials are studying whether IMVT-1402 can help people with generalized myasthenia gravis. The main focus is on safety and on whether symptoms and daily function improve.
  • Who can join the trial? The study is for participants with mild to severe generalized myasthenia gravis. It specifically includes antibody-positive participants for the main outcome measure.
  • What phase is the IMVT-1402 trial? The trial listed is Phase 3. Phase 3 studies are usually larger studies that look closely at how well a treatment works and how safe it is.
  • What condition is the trial focused on? The trial is focused on generalized myasthenia gravis. This is a condition that affects muscle strength and can make daily activities harder.
  • What result is the study measuring? The main result is the change from baseline in MG-ADL score. MG-ADL is a scale that measures how much myasthenia gravis affects daily activities.

Ongoing Clinical Trials on IMVT-1402

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Glossary

  • Generalized myasthenia gravis: A disease that causes muscle weakness in more than one part of the body. It can affect activities like talking, swallowing, and walking.
  • Antibody-positive: This means a blood test shows certain antibodies are present. In this trial, the main outcome is measured in antibody-positive participants.
  • Phase 3: A late-stage clinical trial that usually includes more participants. It helps researchers learn more about how well a treatment works and how safe it is.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: A look-alike treatment with no active substance. It is used to compare results fairly.
  • Subcutaneous: Given under the skin, usually by injection.
  • MG-ADL score: A score that measures how myasthenia gravis affects daily life, such as chewing, speaking, and breathing.
  • Baseline: The starting point before treatment begins. Results are compared with this first measurement.
  • Efficacy: How well a treatment works.
  • Safety: How well a treatment is tolerated and whether it causes problems.

References