Long-term safety and efficacy study of riliprubart in participants with CIDP
EU CTIS ID: 2024-517032-22-00
What this study is testing
To determine the long-term safety and tolerability of riliprubart in participants with CIDP.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, or Study EFC18156. (Participants receiving riliprubart in Part C of PDY16744 are eligible after completing the Part C End of Treatment visit.)
- All participants must agree to use contraception methods during and after the study as required. Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participant must be capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
You likely can't join if
- Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.
- Clinical diagnosis of systemic lupus erythematosus (SLE).
- History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.
- Any country-related specific regulation that would prevent the participant from entering the study.
- Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized.
- Unsuitability for participation as judged by the Investigator, whatever the reason, including: medical or clinical condition, potential risk of participant noncompliance with study procedures, or any other clinically significant change in the participants’ medical condition.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Brazil
- United Kingdom
- Serbia
- Israel
- Japan
- Canada
- Korea, Republic of
- Switzerland
- Chile
- Argentina
- Mexico
- United States
- China
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Brazil; United Kingdom; Serbia; Israel; Japan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.