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AUR200

Clinical trials are investigating AUR200 in people with generalized myasthenia gravis. The studies are looking at safety, tolerability, and whether AUR200 can improve daily function in this condition. The trial data describe an interventional, placebo-controlled study in adults with generalized myasthenia gravis.

Table of Contents

Trial overview

This clinical trial is studying AUR200 in people with generalized myasthenia gravis, a condition that causes muscle weakness in many parts of the body.[1] The study is designed to look at both safety and early signs that the treatment may help with daily life in this disease.[1]

Study design and treatment groups

The trial is described as a double-blind, randomized, placebo-controlled study.[1] This means people are assigned by chance to a study group, and neither the participant nor the study team knows who receives AUR200 or placebo during the study.[1]

The intervention is given by subcutaneous injection, which means an injection under the skin.[1] The source data list AUR200 and a placebo-like comparison treatment as the study interventions.[1]

Who can participate

The trial is for patients with generalized myasthenia gravis.[1] The source data do not provide more detailed entry rules, so exact eligibility depends on the study screening process.[1]

What researchers are measuring

In Phase 1, the main outcome is the incidence of treatment-emergent adverse events, which means how often new health problems or worsening health problems happen after treatment starts.[1] This part of the study is focused on safety and tolerability.[1]

The brief summary also describes a Phase 2 part that looks at efficacy, which means whether the treatment works.[1] The main Phase 2 outcome is the change from baseline in MG-ADL total score, a measure of how much myasthenia gravis affects daily activities such as speaking, chewing, and walking.[1]

Trial status and size

The study status is Authorised.[1] The planned enrollment is 51 participants, which means the trial is designed to include 51 people in total.[1]

Because this is a small early-stage study, the main goal is to learn whether AUR200 can be studied safely in this patient group and whether there are early signs of benefit.[1]

Trial ID Phase Condition studied Status Enrollment
2025-525127-27-00 Phase 1 Generalized Myasthenia Gravis Authorised 51

FAQ

  • What is being studied in the AUR200 trial? The trial is studying AUR200 in people with generalized myasthenia gravis. It compares AUR200 with placebo, which is a look-alike treatment with no active study drug.
  • Who can take part in the study? The trial is for patients with generalized myasthenia gravis. The source data do not give more detailed entry rules, so exact participation depends on the study team’s screening.
  • What phase is the AUR200 trial? The trial is listed as Phase 1. The brief summary also describes a Phase 2 part, which means the study is looking at both safety and early signs of benefit.
  • What results are the researchers measuring? In Phase 1, the main result is the number of treatment-emergent adverse events, which means health problems that start or get worse after treatment begins. In Phase 2, the main result is the change in MG-ADL score, a measure of how much myasthenia gravis affects daily activities.
  • What does generalized myasthenia gravis mean? It is a disease that causes muscle weakness and can affect many parts of the body. The trial is studying whether AUR200 may help improve daily function in people with this condition.

Ongoing Clinical Trials on AUR200

  • AUR200 for Patients with Generalized Myasthenia Gravis

    Recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Generalized myasthenia gravis: A disease that causes weakness in muscles throughout the body, not just in one area.
  • Interventional study: A clinical trial where researchers give a treatment or compare treatments to see what happens.
  • Placebo: A look-alike treatment with no active study drug. It helps show whether the study drug works better than no active treatment.
  • Randomized: Participants are assigned by chance to different study groups.
  • Double-blind: Neither the participant nor the study team knows who is getting the study drug or placebo during the trial.
  • Safety: How well a treatment can be used without causing unacceptable harm.
  • Tolerability: How well people can handle a treatment and its effects during the study.
  • Efficacy: How well a treatment works for the condition being studied.
  • Treatment-emergent adverse events: Health problems that start or become worse after the study treatment begins.
  • MG-ADL score: A score that measures how much myasthenia gravis affects daily activities such as speaking, chewing, or walking.

References

  1. https://clinicaltrials.gov/study/2025-525127-27-00