This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
Description
This is a single-arm study. All participants transitioning to Study LTS17261 will receive riliprubart weekly for up to 3 years, or until commercialization of riliprubart for the treatment of CIDP or termination of the riliprubart clinical development program for the treatment of CIDP, or the local availability of other options for long-term treatment with riliprubart, whichever comes first.
The total number of study visits will be 12.
Who can participate
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. 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.)
2. 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.
3. 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 informed consent form (ICF) and in this protocol.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1. Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
2. Clinical diagnosis of systemic lupus erythematosus (SLE)
3. History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody
4. Any country-related specific regulation that would prevent the participant from entering the study
5. Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized
6. 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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Interventions
Riliprubart Prefilled Pen (PFP)
DRUG
Locations
44
Argentina (1)
Investigational Site Number : 0320003
Buenos Aires
Brazil (1)
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004
Ribeirão Preto , São Paulo
Canada (2)
Investigational Site Number : 1240001
Gatineau , Quebec
Investigational Site Number : 1240002
Québec , Quebec
Chile (2)
Investigational Site Number : 1520003
Lo Barnechea , Reg Metropolitana de Santiago
Investigational Site Number : 1520002
Santiago , Reg Metropolitana de Santiago
China (8)
Investigational Site Number : 1560013
Beijing
Investigational Site Number : 1560005
Beijing
Investigational Site Number : 1560011
Chengdu
Investigational Site Number : 1560002
Fuzhou
Investigational Site Number : 1560012
Guangzhou
Investigational Site Number : 1560001
Shanghai
Investigational Site Number : 1560003
Wuhan
Investigational Site Number : 1560006
Wuhan
Czech Republic (2)
Investigational Site Number : 2030004
Brno
Investigational Site Number : 2030001
Prague
Denmark (1)
Investigational Site Number : 2080002
Aarhus
France (4)
Investigational Site Number : 2500007
Bordeaux
Investigational Site Number : 2500001
Le Kremlin-Bicêtre
Investigational Site Number : 2500002
Marseille
Investigational Site Number : 2500004
Paris
Germany (2)
Investigational Site Number : 2760002
Göttingen
Investigational Site Number : 2760004
Tübingen
Italy (6)
Investigational Site Number : 3800003
Genoa , Genova
Investigational Site Number : 3800001
Milan , Milano
Investigational Site Number : 3800005
Pavia
Investigational Site Number : 3800007
Pisa
Investigational Site Number : 3800002
Rome , Roma
Investigational Site Number : 3800004
Rozzano , Milano
Japan (2)
Investigational Site Number : 3920012
Higashi-Matsuyama , Saitama
Investigational Site Number : 2500005
Toyama
Netherlands (1)
Investigational Site Number : 5280001
Amsterdam
Poland (1)
Investigational Site Number : 6160001
Lublin , Lublin Voivodeship
Portugal (1)
Investigational Site Number : 6200004
Lisbon
Serbia (1)
Investigational Site Number : 6880001
Belgrade
South Korea (1)
Investigational Site Number : 4100003
Seoul , Seoul-teukbyeolsi
Spain (5)
Investigational Site Number : 7240001
Barcelona , Catalunya [Cataluña]
Investigational Site Number : 7240002
Barcelona
Investigational Site Number : 7240004
Majadahonda , Madrid
Investigational Site Number : 7240008
Málaga
Investigational Site Number : 7240003
Valencia
Sweden (1)
Investigational Site Number : 7520001
Stockholm
United States (2)
Alabama Neurology Associates- Site Number : 8400019
Homewood , Alabama
University of Kansas Medical Center (KUMC)- Site Number : 8400010