Diagnosed With Multifocal Motor Neuropathy (MMN)?
Find out about a new clinical study in MMN and if you are eligible to participate.
CLINICALTRIALS.GOV ID: NCT05225675
With your participation, you may be able to help researchers investigate a potential treatment for Multifocal Motor Neuropathy (MMN)
About Multifocal Motor Neuropathy (MMN)
MMN is a disorder in which your immune system produces antibodies which normally target bacteria or infection, but instead attack your own nervous system. It causes weakness, without loss of sensation, in your hands, arms, and/or legs, so you may not be able to engage in your normal work and daily activities, and the damage can get worse over time.
What causes nerve damage in MMN?
In MMN, the production of autoantibodies and the overactivation of the complement system, a part of the immune system, causes damage to the nervous system
About the Investigational Study Drug
Participants will be given either the investigational study drug (active) or placebo (inactive) by intravenous infusion.*
A computer will randomly assign participants to either the investigational study drug or placebo.
You have 2 chances out of 3 to receive the investigational study drug and 1 chance out of 3 to receive placebo.
Neither you nor the study doctor will know whether you receive the investigational study drug or placebo. In an emergency, the study doctor can obtain this information.
If during the study, should symptoms of your MMN require additional control, your study doctor can administer Intravenous Immunoglobulin (IVIg).
*Initial infusion at the study site during the study treatment period is expected to take 2 hours. For following visits during this period, the infusion will take 1 hour.
The investigational study drug is currently not approved for use in multifocal motor neuropathy (MMN) by any regulatory agency, as its safety and effectiveness have not been established for the treatment of MMN
If you receive IVIg every 2-5 weeks to control your Multifocal Motor Neuropathy (MMN), you may be able to participate in a study for MMN*
*Other eligibility criteria apply
About the ARDA Study | Who Can Participate
To participate in the study you, or the person you care for, must be:
18 years of age or older
Diagnosed with multifocal motor neuropathy (MMN)
Currently receiving intravenous immunoglobulin (IVIg) for MMN, every 2-5 weeks
Not pregnant or intending to get pregnant in the next few years
There are additional study requirements that patients must meet in order to take part in this study. A study representative will discuss them with you.
How to Participate
Why IVIg?
Currently, the only approved treatment for MMN is intravenous immunoglobulin (IVIg). One of the requirements to join the study, is that participants must be receiving frequent IVIg treatment (every 2-5 weeks). During the study, participants may be treated with IVIg, if required. A study representative will discuss this with you.
Is the ARDA Study Right for You?
Please answer the following questions to see if you, or the person you care for, may be eligible to participate in the ARDA Study:
Frequently Asked Questions
What is this study about?
This study aims to evaluate the safety and tolerability of the investigational study drug compared to placebo (a treatment that looks like the investigational study drug and is given the same way, but has no active ingredients) in adults with multifocal motor neuropathy (MMN) who regularly receive intravenous immunoglobulin (IVIg). The investigational study drug is currently not approved for use in MMN by any regulatory agency, as its safety and effectiveness have not been established for the treatment of MMN.
Who can take part?
Participants must be adults, aged 18 or over, with a confirmed diagnosis of MMN who are currently receiving intravenous immunoglobulin (IVIg) every 2-5 weeks. Both men and women of child-bearing age must be willing to use contraceptives for the duration of the study to avoid pregnancy.
What is the investigational study drug?
In some diseases, antibodies can attack your own body. ARGX-117 is a new compound that is being investigated in the ARDA study for its use in treating diseases that are mediated by the complement system. The complement system is part of the immune system. It plays a central role in the body’s defense against infections. In diseases like MMN, the immune system activates complement, which causes damage to the nervous system. The investigational study drug (ARGX-117) is currently not approved for use in multifocal motor neuropathy (MMN) by any regulatory agency, as its safety and effectiveness have not been established for the treatment of MMN.
What are the chances of getting the investigational study drug?
At the start of the study treatment period, participants will be randomly assigned by chance, like the flipping of a coin, to either the ARGX-117 group or the placebo group. Participants have 2 chances out of 3 to receive ARGX-117 (active study drug) through an infusion. So participants have 1 chance out of 3 to receive placebo (inactive study drug), also given as an infusion.
Will there be any costs associated with participation in the study?
There will be no costs associated with participation in the study. Participants will receive the study drug, tests, examinations, and medical care related to the study at no charge. Participants may also be reimbursed for travel to the study center for study visits.
What is involved in taking part in the ARDA study?
First, participants will be asked to come into a study site for screening, where they will be examined and receive testing to see if the study is appropriate.
During the study, participants will be asked to come to the study site during the IVIg dependency period (for only some participants) and the IVIg monitoring period (for all participants) based on how often they would normally receive IVIg.
During the study treatment period, participants will be asked to come to the study site for 3 visits on days 1, 4 and 8, with the visit on day 4 being optional. Then once a week for 3 weeks.
After that, participants will be asked to come to the study site up to 8 more times.
What happens after the treatment period is completed?
After the study treatment period, participants will enter the 12-month safety follow-up period. Alternatively, if participants are eligible, they can choose to take part in a long term study that continues to evaluate the safety of ARGX-117. In that study, all participants will receive ARGX-117. If participation is discontinued at any time after receiving treatment, a 12-month safety follow-up period is required.
How do I find out more about participating in the ARDA study?
If you are interested in taking part in the study and would like more information, click here to talk to a Know Rare patient advocate.
Resources
Sources:
1. Data on file, argenx 2022
2. https://clinicaltrials.gov/ct2/show/NCT05225675
ARGX-117-2002_Patient Website_V1_R4_09DEC2022_US
MED-US-a117-2200005
