Active not recruitingPHASE2INTERVENTIONAL

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

This study is for adults with a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is an autoimmune disease where your body's immune system mistakenly attacks your nerves, causing weakness and other symptoms. The study is testing a drug called efgartigimod, given as an injection under the skin, to see how well it works and if it's safe over a long period. This is an extension of a previous study. Participants who are doing well on the drug might also get the chance to try taking it less frequently to see if that's also effective. This research helps us understand more about managing CIDP with this new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

argenx

Enrolment target

229

Start

18 Sep 2020

Estimated completion

30 Apr 2027

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

What is this study about?

This study is looking into a new treatment for a condition called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP is a long-term illness where your body's defence system mistakenly attacks the protective cover of your nerves. This can lead to muscle weakness, numbness, and tingling, often getting worse over time. The drug being tested is called efgartigimod, and it's given as an injection just under the skin.

The main goal of this particular study is to check how safe and effective efgartigimod is when used over a longer time. It's a follow-up for people who have already been taking the drug in a previous study. By continuing to monitor these patients, researchers can gather important information about its long-term effects and how well it helps manage CIDP symptoms.

An interesting part of this study is that some participants who are stable on efgartigimod might get the chance to try taking the medicine less often. This helps researchers understand if patients can still get the benefits of the drug with fewer injections, which could make treatment more convenient in the future. This research is important for improving our understanding and treatment options for people living with CIDP.

Key takeaways

This study is testing a drug called efgartigimod for CIDP.
It's for adults who have already been part of a previous study with this drug.
The study wants to learn about the drug's long-term safety and how well it works.
Some people might try taking the drug less often to see if it's still effective.
It’s an injection given under the skin.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) who has already participated in a specific previous study (called ARGX-113-1802) for efgartigimod. This means you would have already completed a certain part of that study, or perhaps that study ended early, and you were invited to continue with this one.

Women who could become pregnant will need to take a pregnancy test to ensure they are not pregnant before starting the study drug. If you are a woman who could become pregnant, you'll also need to use reliable birth control methods throughout the study, from when you agree to join until your last dose of the study drug.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you cannot participate. You also can't join if you have another serious illness, recently had or are planning major surgery, or are taking certain medications that are not allowed in this study. The medical team will check all these details carefully to make sure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you already been in the previous efgartigimod study (ARGX-113-1802)?
Are you not pregnant or breastfeeding, and not planning to become pregnant during the study?
Do you not have any other serious health conditions or upcoming major surgeries that might prevent you from joining?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

This study is an extension, so you would likely continue your current treatment schedule with efgartigimod, given as an injection under the skin. The actual visit schedule and assessments would be discussed with you, but typically, long-term studies involve regular check-ups to monitor your health, how you're feeling, and how the drug is working. These might include physical examinations, blood tests, and questions about your symptoms.

For some participants, there might be an opportunity to take part in a separate part of the study where the dose of efgartigimod might be given less frequently. This would involve close monitoring to see if the new schedule is still effective for you. The total duration of your participation would depend on the study plan, but as a long-term extension, it could be for an extended period, with ongoing follow-up. You'll receive specific details about appointments and what's involved from the study team.

Potential risks and benefits

Participating in this study could potentially offer ongoing management for your CIDP with efgartigimod, which you've already been receiving, and contribute to understanding its long-term effects. For some, there might be the added benefit of trying a less frequent dosing schedule, which could improve convenience. As with all medicines, there's always a possibility of side effects, though these would have been monitored in the previous study. There's also the commitment of attending regular appointments. Remember, joining is always your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (147)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Investigator site 0010065
Verified postcode
Birmingham, United States
Investigator site 0010013
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Phoenix, United States
Investigator site 0010055
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Scottsdale, United States
Investigator site 0010032
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Carlsbad, United States
Investigator site 10190
Verified postcode
Pomona, United States
Investigator site 0010160
Verified postcode
Rancho Mirage, United States
Investigator site 0010071
Verified postcode
San Francisco, United States
Investigator site 0010057
Verified postcode
Centennial, United States
Investigator site 0010072
Verified postcode
Boca Raton, United States
Investigator site 0010144
Verified postcode
Coral Springs, United States
Investigator site 0010023
Verified postcode
Jacksonville, United States
Investigator site 0010068
Verified postcode
Maitland, United States

Common questions

What is CIDP?

CIDP is a long-term condition where your body's immune system attacks your nerves, causing weakness and numbness.

What is efgartigimod?

It's a study drug given as an injection under the skin, being tested to see how it helps people with CIDP.

Why is this study being done?

This study aims to understand how safe and effective efgartigimod is for CIDP over a longer period, and if it can be given less often.

Who can join this study?

Generally, adults who have already taken part in a specific previous study for efgartigimod and meet certain health criteria.

Can I stop participating if I want to?

Yes, you are always free to leave the study at any time, for any reason, and it won't affect your medical care.