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RecruitingPHASE3INTERVENTIONAL

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This research study is looking for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are currently receiving a regular treatment called IVIg (intravenous immunoglobulin). The main goal is to compare a new medicine, riliprubart, with the IVIg treatment you might already be getting. Researchers want to see if riliprubart is effective and safe in managing CIDP symptoms. The new medicine or a dummy treatment (placebo) will be given alongside IVIg, to understand which approach helps people living with this condition. The study will last for about two years, including check-ups before, during, and after the main treatment period.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Sanofi
Enrolment target
160
Start
21 Aug 2024
Estimated completion
12 Jan 2029

What is this study about?

This study is about a condition called Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. If you have CIDP, your body's immune system mistakenly attacks the protective covering of your nerves, making them less able to send messages. This can lead to muscle weakness, numbness, and other symptoms. Many people with CIDP receive a treatment called Intravenous Immunoglobulin, or IVIg, which helps calm the immune system.

Researchers are investigating a new medicine called riliprubart. They want to find out if riliprubart can be a good treatment for CIDP, especially for adults who are already on regular IVIg treatment. The study will compare riliprubart with IVIg to see how well it works and if it's safe.

The study aims to improve treatments available for people with CIDP. By taking part, you could contribute to a better understanding of how new medicines can help manage this condition, potentially leading to more options for patients in the future.

Key takeaways

  • This study is for adults with CIDP who are already on regular IVIg treatment.
  • It compares a new medicine, riliprubart, with existing IVIg treatment.
  • Participation lasts for about two years, with regular check-ups.
  • You might receive riliprubart, IVIg, or a dummy treatment (placebo).
  • The aim is to find effective and safe ways to manage CIDP.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older with a confirmed diagnosis of CIDP, or a type of CIDP such as motor CIDP or multifocal CIDP (also known as Lewis Sumner Syndrome). Your diagnosis will be re-checked by a special group of experts for the study.

You must also have responded well to IVIg treatment in the past five years and currently be receiving regular, stable IVIg doses. It's important that you still have some ongoing difficulties from your CIDP, even with IVIg, and that your condition shows some signs of being active. Your weight should be between 35 kg and 154 kg.

There are also some requirements about being up-to-date with certain vaccinations before starting the study medicine. If you are sexually active, you'll need to use effective contraception, and pregnant or breastfeeding individuals cannot take part. Men cannot donate sperm during the study. If you normally have IVIg at home, you'll need to switch to having it at a hospital or clinic before joining.

Quick self-check
  • Are you an adult (18 years or older) with CIDP?
  • Have you responded to IVIg in the past 5 years and are you currently on stable IVIg doses?
  • Do you still experience some difficulties from your CIDP?
  • Are you able to attend clinic visits for up to two years?
  • Are you between 35 kg and 154 kg (77 to 340 lbs)?
  • Are you willing to use effective contraception if sexually active?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will last for up to 109 weeks, which is about two years. It starts with an initial check-up phase to ensure you meet all the requirements. You'll then go through different treatment phases where you might receive the new medicine (riliprubart), IVIg, or a placebo (a dummy treatment designed to look like the real thing but with no active medicine).

Throughout the study, you'll have regular visits to the clinic for assessments, which will include examinations, questionnaires about your symptoms and how you are feeling, and possibly blood tests. These checks help the study doctors understand how your condition is responding and monitor your health carefully. There will also be follow-up appointments after your main treatment period to ensure your wellbeing.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as receiving close medical attention, regular health monitoring, and access to a new investigational treatment that might help your CIDP. However, there are also potential risks involved, similar to any medical treatment or research study. These could include side effects from the study medicines, which will be carefully monitored. The study also involves a commitment of time for clinic visits and assessments. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (123)

  • Alabama Neurology Associates- Site Number : 8400019
    Homewood, United States· Recruiting
  • Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
    Scottsdale, United States· Recruiting
  • Keck School of Medicine of University of Southern California- Site Number : 8400002
    Los Angeles, United States· Recruiting
  • University of California Irvine Medical Center- Site Number : 8400007
    Orange, United States· Recruiting
  • Yale University School of Medicine- Site Number : 8400018
    New Haven, United States· Recruiting
  • Nova Clinical Research - Bradenton- Site Number : 8400044
    Bradenton, United States· Recruiting
  • AdventHealth Orlando- Site Number : 8400006
    Orlando, United States· Recruiting
  • AdventHealth Site Number : 8400006
    Orlando, United States· Recruiting
  • NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024
    Glenview, United States· Recruiting
  • University of Kansas Medical Center- Site Number : 8400010
    Kansas City, United States· Recruiting
  • Ochsner Medical Center - Jefferson Highway- Site Number : 8400030
    New Orleans, United States· Recruiting
  • Johns Hopkins Hospital- Site Number : 8400015
    Baltimore, United States· Recruiting

+111 more sites — see the official record for the full list.

Common questions

What is CIDP?

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

What is IVIg?

IVIg is a common treatment for CIDP that involves giving healthy antibodies through a drip to help calm the immune system.

What is riliprubart?

Riliprubart is a new investigational medicine being tested in this study to see if it can help manage CIDP.

Will I definitely receive the new medicine?

No, you might receive riliprubart, your usual IVIg, or a placebo (dummy treatment), as part of the study design to compare different approaches.

How long will the study last?

The study will last for a maximum of 109 weeks, which is just over two years, including screening, treatment, and follow-up.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Test the Efficacy and Safety of Riliprubart Again…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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