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Frequently Asked Questions

Below are some frequently asked questions about MycarinGstudy clinical research study.

What is MycarinGstudy?

MycarinGstudy is a clinical research study evaluating the safety and effectiveness of a potential new subcutaneous treatment for generalized myasthenia gravis (gMG) called rozanolixizumab that could improve life for people living with MG. The study was designed with the MG community from several countries, and is structured around the needs of patients like you and tracking the measures that matter most.

In this study, participants 18 years of age and older will be randomized to receive either the study drug or a placebo. A placebo contains no medicinally active ingredients. The 18-week study will consist of a screening period (1-28 days), a study treatment period (6 weeks) and an observation period (8 weeks). Study site visits will consist of tests, disease monitoring and subcutaneous infusion of the study drug, and home visits may be an option for some participants. Participants are allowed to stay on current therapies they use to manage their MG (as long as they are not taking a medication prohibited by the study protocol).

What is a clinical research study?

Clinical research studies can help to advance the understanding of a disease and are the primary way that researchers find out if potential new treatments are well tolerated and effective. New treatments cannot become widely available without these studies.

Who can take part in MycarinGstudy?

To be eligible* for MycarinGstudy you must:

  • Be diagnosed with generalized MG (gMG)
  • Be aged 18 years or older
  • Have mild to severe MG symptoms involving more than just the eyes

There are additional criteria that you will need to meet to enroll in the study—all clinical studies have these entry criteria. They are called inclusion and exclusion criteria and are related to a person’s health when they enter the study. The study team will assess and discuss these with you. You can also ask your doctor to explain the entry criteria (also called eligibility criteria) to see if you may be able to participate in the study.

The inclusion and exclusion criteria are there to make sure the study results will be valid, by having a group of people included who have similar disease characteristics, and to exclude people for whom the study drug might have more risks than benefits. Exclusion criteria are things that you must NOT have at the start of the study.

If you are interested in discovering if you or a loved one may take part in MycarinGstudy, please complete the short prescreener.

Where is MycarinGstudy taking place?

MycarinGstudy is taking place at approximately 100 study site locations around the world. You can use the site finder to see the closest study site location to you. Home visits may be an option for some participants.

Home visits are where a nurse visits you in your home and performs the tests and assessments there without you having to travel to the study site. If you prefer, you can go to the site for these visits instead. Your study doctor will also help to decide if home visits are appropriate for you.

How long will MycarinGstudy take?

MycarinGstudy takes place in several different steps over an 18-week period:

Step 1: Screening (Up to 4 weeks)

  • Confirms you meet the entry criteria.
  • There will be blood/urine tests, physical exams, and health questionnaires.

Step 2: Randomization

  • You will be randomly assigned to receive either the study drug or a placebo. A placebo looks similar to a study drug but contains no medicinally active ingredients.

Step 3: Study Treatment Period
(6 weeks)

  • You will receive 6 subcutaneous (under the skin) infusions of the study drug or placebo, one each week, over a 5-week period.
  • Tests will be done up to week 6 to monitor your health and wellbeing.
  • Optional home visits may be available.

Step 4: Observation Period (8 weeks)

  • The same tests will continue to be done to monitor your health and wellbeing.
  • No study infusions will be given during this time.
  • Optional home visits may be available.

Next Steps: Open-Label Extension Study

  • If you meet the entry criteria, you will be invited to take part in a separate, long-term open-label extension study, during which you will receive rozanolixizumab. The MycarinGstudy extension provides an additional study treatment period of 52 weeks.
  • The same tests will continue to be done to monitor your health and wellbeing.
  • Optional home visits may be available.

Can I keep my current doctor?

We encourage you to continue seeing your usual doctor and update them on how you are progressing in the study.

What is MG?

MG causes weakness of muscles involved in movement and/or breathing. This is an “autoimmune disorder” which means that it is caused by your antibodies. These antibodies usually fight foreign substances and organisms that can cause infections. In the case of autoimmune disorders, these antibodies cannot differentiate between foreign proteins (from bacterial or viral agents or other substances) and the proteins from the body’s own cells. As a result they end up targeting and destroying the body’s own proteins along with the foreign ones. In the case of MG, these antibodies target and destroy proteins that are responsible for communication between nerves and muscles. This then results in muscle weakness. The antibodies which target the body’s own proteins are called auto-antibodies.

What is rozanolixizumab?

Rozanolixizumab is a type of antibody that helps break down circulating antibodies, including harmful auto‑antibodies, lowering their levels in blood. Rozanolixizumab is administered via a subcutaneous infusion under the skin, and is not an intravenous (IV) drug.

Will I receive compensation for my participation in the MycarinGstudy?

Costs for travel to and from the study site can be reimbursed. Please ask your study doctor to provide you with the information. Study drug will be provided at no charge by UCB during your participation in this trial. You will not be charged for any procedure performed for the purpose of this study. The cost of any other drugs or medical procedures (outside this study, eg. IVIg or PEX) that you may use/need during the trial will not to be covered by UCB.

Why should I participate in a clinical study?

People decide to participate in clinical studies for a variety of reasons. Some wish to contribute to medical research and to potentially help others with the same condition. Others may wish to try a different approach to treatment. Clinical studies are completely voluntary, and you can withdraw at any time without providing a reason.

What happens when the study is over?

Eligible participants will be invited to take part in an open-label extension study. During this extension study, all participants will receive the study drug. Open-label extension studies allow researchers to track the effectiveness and safety of treatments over longer periods of time.

Who is UCB?

UCB, a global biopharmaceutical company based in Belgium, is developing rozanolixizumab and is sponsoring MycarinGstudy.

We have listened and will keep listening to the evolving needs of participants throughout MycarinGstudy. UCB is engaging with organizations that support people with MG to better understand their needs.

How would my safety be protected?

We want every participant to feel comfortable. An essential part of any clinical study is keeping track of any side-effects that participants experience.

Tracking side-effects helps researchers analyze if the treatment is well tolerated. If specific and/or severe side-effects occur while you are participating in MycarinGstudy, your dedicated study team will take action.

In addition, MycarinGstudy will be regularly reviewed by an independent data and safety monitoring board in order to identify and address any safety concerns that may arise.

MycarinGstudy is currently enrolling

We are looking to partner with the MG community and their doctors to help evaluate a potential new subcutaneous treatment option.

Find a study site

MycarinGstudy will be completed at approximately 100 study sites around the world.