Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

Официальное название

Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Riliprubart Prefilled Pen (PFP)
  Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Первичные конечные точки

• Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period [Срок оценки: Up to End of Study (approx. 4 years)]

Вторичные конечные точки (6)

• Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156) [Срок оценки: From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)]
• Percentage of participants experiencing improvement from baseline [Срок оценки: From Baseline to 3 years]
• Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time [Срок оценки: From Baseline to 3 years]
• Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time [Срок оценки: From Baseline to 3 years]
• Change from baseline in grip strength (kilopascals; dominant hand) over time [Срок оценки: From Baseline to 3 years]
• Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time [Срок оценки: From Baseline to 3 years]

Критерии участия

Критерии включения

Participants are eligible to be included in the study only if all of the following criteria apply:

• 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 informed consent form (ICF) and in this protocol.

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• 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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

• Investigational Site Number : 1560013 — Пекин
• Investigational Site Number : 1560005 — Пекин
• Investigational Site Number : 1560011 — Чэнду
• Investigational Site Number : 1560002 — Фучжоу
• Investigational Site Number : 1560012 — Гуанчжоу
• Investigational Site Number : 1560001 — Шанхай
• Investigational Site Number : 1560003 — Ухань
• Investigational Site Number : 1560006 — Ухань

Италия · 6 центров

• Investigational Site Number : 3800003 — Genoa
• Investigational Site Number : 3800001 — Milan
• Investigational Site Number : 3800004 — Rozzano
• Investigational Site Number : 3800002 — Rome
• Investigational Site Number : 3800005 — Pavia
• Investigational Site Number : 3800007 — Pisa

Испания · 5 центров

• Investigational Site Number : 7240001 — Barcelona
• Investigational Site Number : 7240004 — Majadahonda
• Investigational Site Number : 7240002 — Barcelona
• Investigational Site Number : 7240008 — Málaga
• Investigational Site Number : 7240003 — Valencia

Франция · 4 центра

• Investigational Site Number : 2500007 — Bordeaux
• Investigational Site Number : 2500001 — Le Kremlin-Bicêtre
• Investigational Site Number : 2500002 — Marseille
• Investigational Site Number : 2500004 — Paris

США · 3 центра

• Alabama Neurology Associates- Site Number : 8400019 — Homewood
• University of Kansas Medical Center- Site Number : 8400010 — Kansas City
• Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022 — Philadelphia

Германия · 3 центра

• Investigational Site Number : 2760002 — Göttingen
• Investigational Site Number : 2760003 — Münster
• Investigational Site Number : 2760004 — Tübingen

Япония · 3 центра

• Investigational Site Number : 3920012 — Higashi-Matsuyama
• Investigational Site Number : 3920011 — Bunkyo-Ku
• Investigational Site Number : 2500005 — Toyama

Канада · 2 центра

• Investigational Site Number : 1240001 — Gatineau
• Investigational Site Number : 1240002 — Québec

Чили · 2 центра

• Investigational Site Number : 1520003 — Lo Barnechea
• Investigational Site Number : 1520002 — Santiago

Чехия · 2 центра

• Investigational Site Number : 2030004 — Brno
• Investigational Site Number : 2030001 — Prague

Аргентина · 1 центр

• Investigational Site Number : 0320003 — Buenos Aires

Бразилия · 1 центр

• Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004 — Ribeirão Preto

Дания · 1 центр

• Investigational Site Number : 2080002 — Aarhus

Мексика · 1 центр

• Investigational Site Number : 4840001 — Tlalnepantla

Нидерланды · 1 центр

• Investigational Site Number : 5280001 — Amsterdam

Польша · 1 центр

• Investigational Site Number : 6160001 — Lublin

Португалия · 1 центр

• Investigational Site Number : 6200004 — Lisbon

Сербия · 1 центр

• Investigational Site Number : 6880001 — Belgrade

South Korea · 1 центр

• Investigational Site Number : 4100003 — Seoul

Швеция · 1 центр

• Investigational Site Number : 7520001 — Stockholm

Turkey (Türkiye) · 1 центр

• Investigational Site Number : 7920003 — Konya

Идентификаторы

NCT: NCT06859099 · LTS17261 · U1111-1311-1432 · 2024-517032-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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