What is the MyClad Study?

The MyClad Study is a clinical research study (also called a clinical trial) looking to evaluate an investigational medication taken by mouth regarding its ability to treat people with generalized myasthenia gravis.

The investigational medication is a version of a medication currently approved in the United States (US), European Union (EU), and other countries for the treatment of other indications. The investigational medication will be given as a capsule to be swallowed.

Up to a possible 264 people will take part in this study. Participation will last for about 3 years.

 

MyClad Study quick facts

If you choose to enroll, you may be in the study for about 3 years.

In this clinical research study, the investigational medication (taken by mouth) is being compared with a placebo. A placebo is a drug that contains no active ingredients. It is used to help researchers understand whether the effects seen in the study are because of the investigational medication. The investigational medication and placebo will together be referred to as the study medication.

Up to 264 people are expected to take part in this study.

Several tests and assessments will be performed to monitor participant health. These will include:

  • Questions about the participant and their medical history
  • A check of vital signs (blood pressure, heart rate, etc.)
  • A full physical examination including blood tests, urine tests, a brain magnetic resonance imaging (MRI) scan (if you haven’t had one in the previous 3 months), and an electrocardiogram (ECG)

What to expect in the MyClad Study

The study periods

The study is divided into 3 periods:

1. Screening period (up to 8 weeks)

You will have an appointment at the study center to see if the study is suitable for you and if you want to take part. You can ask any questions during this period and receive all the information you need to make your decision.

You may also need to complete a “washout” period. This may be necessary if you are currently on certain medications that might need to be discontinued. Your study doctor will discuss this with you.

2.  Study treatment period (about 3 years)

The study treatment period is divided into 3 periods.

  • Period 1
    • You, as a participant, will take the study medication over 2 treatment courses separated by 4 weeks. You will take the study medication as capsules by mouth.
  • Period 2 
    • You will take a different study medication in the same way as during Period 1 (over 2 treatment courses separated by 4 weeks).
  • Period 3 
    • In Period 3, the study doctor will continue to check your health. If your study doctor thinks it is appropriate, you may receive re-treatment with the study medication.

*Please note that the dosing might be adapted or changed during the study if necessary.

3. End of study period

After your last study treatment period visit, you will be asked to visit the study center once more 4 weeks later for an end of study visit. During this visit, the study doctor will do some final checks and assessments of your health.

The investigational medication

The investigational medication tries to recognize and remove some types of cells that your immune system uses to fight diseases. Usually, these blood cells help support the immune system, but for people like you with generalized myasthenia gravis (gMG), the cells do not work properly.

We want to evaluate the ability to improve your gMG symptoms with the investigational medication by removing some of these cells in your blood.

 

 

Please Click the Contact button at the bottom of the page or Top right of the page to Volunteer Today!