Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
This study is checking the long-term safety and how well a new medicine, riliprubart, works for adults who have a nerve condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It's an extension study for people who have already completed an earlier phase of treatment with riliprubart in one of three other studies. Participants will continue to receive riliprubart using a special pen. The study will last up to four years, with treatment for about three years. Even if someone stops the medicine, they will be checked for safety for more than a year afterwards. This helps us understand the full effects of the treatment over time.
At a glance
What is this study about?
This study is about a medicine called riliprubart for people with a long-term nerve condition known as Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP is a condition where the body's immune system mistakenly attacks the protective covering of nerves, which can lead to weakness, numbness, and other problems.
The main goal of this particular study is to see how safe riliprubart is and how well it continues to work over a long period. It's a follow-on study for people who have already taken riliprubart in one of three previous studies. If you've been in one of those previous trials (PDY16744, EFC17236, or EFC18156) and want to keep taking the medicine, this study offers that chance.
Researchers want to learn more about the long-term effects of riliprubart because understanding how a medicine works and if it remains safe over many months and years is very important before it can be widely used. The study will last up to four years for each person, with the treatment phase lasting up to three years. Your participation helps doctors learn crucial information to help future patients with CIDP.
Key takeaways
- This study is for adults with CIDP who previously received riliprubart in a clinical trial.
- It aims to study the long-term safety and effectiveness of riliprubart.
- Participants will continue to use riliprubart weekly via a pre-filled pen.
- The study involves up to 12 visits over a maximum of 4 years.
- Your contribution helps scientists understand this treatment better.
Who may be eligible?
This study is for adults aged 18 and over, of any gender. To join, you must have CIDP and have already completed treatment in Part B of one of the previous riliprubart studies (PDY16744, EFC17236, or EFC18156). If you were in Part C of study PDY16744, you can join after finishing your treatment visit for that part.
You also need to agree to use reliable contraception during and after the study, following local rules for clinical trials. You must be able to understand the study information and give your written permission to take part, and be willing to follow all the study's rules and appointments.
You cannot join if you are pregnant or breastfeeding, or if you have a condition called systemic lupus erythematosus (SLE). You're also excluded if you've had a bad allergic reaction to riliprubart or any similar medicines. The study cannot accept people if your doctor thinks it's not suitable for you for health reasons, or if there's a risk you might not be able to follow the study plan.
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?
- Do you have CIDP?
- Have you previously completed treatment in Part B of studies PDY16744, EFC17236, or EFC18156?
- Are you able to use reliable contraception if needed?
- Are you not currently pregnant or breastfeeding?
What does participation involve?
If you decide to join this study, you will continue to receive the riliprubart medicine weekly using a special pre-filled pen. The treatment part of the study could last for up to three years. You'll need to attend a total of 12 study visits over this time, where doctors will check on your health and how the treatment is working.
The overall time you'll be part of the study, including a follow-up period after you stop taking the medicine, will be up to four years. If you stop taking riliprubart at any point, the study team will still follow up with you for at least 55 weeks (just over a year) to check on your safety.
Potential risks and benefits
Locations (45)
- Alabama Neurology Associates- Site Number : 8400019Verified postcodeHomewood, United States
- University of Kansas Medical Center- Site Number : 8400010Verified postcodeKansas City, United States
- Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022Verified postcodePhiladelphia, United States
- Investigational Site Number : 0320003Verified postcodeBuenos Aires, Argentina
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004Verified postcodeRibeirão Preto, Brazil
- Investigational Site Number : 1240001Verified postcodeGatineau, Canada
- Investigational Site Number : 1240002Verified postcodeQuébec, Canada
- Investigational Site Number : 1520003Verified postcodeLo Barnechea, Chile
- Investigational Site Number : 1520002Verified postcodeSantiago, Chile
- Investigational Site Number : 1560013Verified postcodeBeijing, China
- Investigational Site Number : 1560005Verified postcodeBeijing, China
- Investigational Site Number : 1560011Verified postcodeChengdu, China
Common questions
What is CIDP?
CIDP is a long-lasting condition where your body's defence system attacks nerves, leading to weakness and numbness.
Who is this study for?
It's for adults with CIDP who have already taken riliprubart in one of three specific previous studies.
How will I take the medicine?
You'll take riliprubart once a week using a pre-filled pen.
How long will I be in the study?
The study could last up to four years, with treatment for up to three years. There will be 12 visits in total.
Can I stop taking part if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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