Studio di sicurezza ed efficacia a lungo termine di Riliprubart nei partecipanti con CIDP (LTS)
Studio di estensione a lungo termine per valutare la sicurezza e l'efficacia di Riliprubart (SAR445088) nei partecipanti con polineuropatia demielinizzante infiammatoria cronica (CIDP)
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, 1221
- Investigational Site Number : 0320003
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São Paulo, Brasile, 04038-002
- PSEG Centro de Pesquisa Clínica- Site Number : 0760009
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Federal District
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Brasília, Federal District, Brasile, 70200-730
- L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
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São Paulo
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Ribeirão Preto, São Paulo, Brasile, 14049-900
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004
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Blagoevgrad, Bulgaria, 2700
- Investigational Site Number : 1000002
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Quebec
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Gatineau, Quebec, Canada, J8Y 1W2
- Investigational Site Number : 1240001
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Québec, Quebec, Canada, G1E 7G9
- Investigational Site Number : 1240002
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Brno, Cechia, 625 00
- Investigational Site Number : 2030004
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Prague, Cechia, 128 08
- Investigational Site Number : 2030001
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Reg Metropolitana de Santiago
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Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
- Investigational Site Number : 1520003
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Puente Alto, Reg Metropolitana de Santiago, Chile, 8207257
- Investigational Site Number : 1520002
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Beijing, Cina, 100034
- Investigational Site Number : 1560013
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Beijing, Cina, 100053
- Investigational Site Number : 1560005
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Changsha, Cina, 410008
- Investigational Site Number : 1560009
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Chengdu, Cina, 610072
- Investigational Site Number : 1560011
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Fuzhou, Cina, 350001
- Investigational Site Number : 1560002
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Guangzhou, Cina, 510000
- Investigational Site Number : 1560012
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Hangzhou, Cina, 310009
- Investigational Site Number : 1560014
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Shanghai, Cina, 200040
- Investigational Site Number : 1560001
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Wuhan, Cina, 430030
- Investigational Site Number : 1560003
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Wuhan, Cina, 430060
- Investigational Site Number : 1560006
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Xi'an, Cina, 710038
- Investigational Site Number : 1560004
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Corea del Sud, 02841
- Investigational Site Number : 4100003
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Aarhus, Danimarca, 8200
- Investigational Site Number : 2080002
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Copenhagen, Danimarca, 2100
- Investigational Site Number : 2080001
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Bordeaux, Francia, 33076
- Investigational Site Number : 2500007
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Le Kremlin-Bicêtre, Francia, 94270
- Investigational Site Number : 2500001
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Marseille, Francia, 13885
- Investigational Site Number : 2500002
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Montpellier, Francia, 34090
- Investigational Site Number : 2500005
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Paris, Francia, 75013
- Investigational Site Number : 2500004
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Göttingen, Germania, 37075
- Investigational Site Number : 2760002
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Münster, Germania, 48149
- Investigational Site Number : 2760003
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Tübingen, Germania, 72076
- Investigational Site Number : 2760004
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Saitama
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Higashi-Matsuyama, Saitama, Giappone, 355-0005
- Investigational Site Number : 3920012
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Tokyo
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Bunkyo-Ku, Tokyo, Giappone, 113-8510
- Investigational Site Number : 3920011
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Kodaira, Tokyo, Giappone, 187-8551
- Investigational Site Number : 3920008
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Pavia, Italia, 27100
- Investigational Site Number : 3800005
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Pisa, Italia, 56126
- Investigational Site Number : 3800007
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Genova
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Genoa, Genova, Italia, 16132
- Investigational Site Number : 3800003
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Milano
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Milan, Milano, Italia, 20132
- Investigational Site Number : 3800001
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Rozzano, Milano, Italia, 20089
- Investigational Site Number : 3800004
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Roma
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Rome, Roma, Italia, 00168
- Investigational Site Number : 3800002
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Tlalnepantla, Messico, 54055
- Investigational Site Number : 4840001
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Amsterdam, Olanda, 1105 AZ
- Investigational Site Number : 5280001
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-954
- Investigational Site Number : 6160001
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Lisbon, Portogallo, 1150-199
- Investigational Site Number : 6200004
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Oxfordshire
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Oxford, Oxfordshire, Regno Unito, OX3 9DU
- Investigational Site Number : 8260001
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Belgrade, Serbia, 11000
- Investigational Site Number : 6880001
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Málaga, Spagna, 29010
- Investigational Site Number : 7240008
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Valencia, Spagna, 46026
- Investigational Site Number : 7240003
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Catalunya [Cataluña]
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Barcelona, Catalunya [Cataluña], Spagna, 08041
- Investigational Site Number : 7240001
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Barcelona, Catalunya [Cataluña], Spagna, 08035
- Investigational Site Number : 7240002
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Madrid
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Majadahonda, Madrid, Spagna, 28222
- Investigational Site Number : 7240004
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Navarre
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Pamplona, Navarre, Spagna, 31008
- Investigational Site Number : 7240006
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Alabama
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Homewood, Alabama, Stati Uniti, 35209
- Alabama Neurology Associates- Site Number : 8400019
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85251
- Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Medical Center- Site Number : 8400010
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University Irving Medical Center- Site Number : 8400003
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
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Stockholm, Svezia, 113 65
- Investigational Site Number : 7520001
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Taipei, Taiwan, 100
- Investigational Site Number : 1580001
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Istanbul, Turchia (Türkiye), 34093
- Investigational Site Number : 7920001
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Konya, Turchia (Türkiye), 42075
- Investigational Site Number : 7920003
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: riliprubart
Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP) |
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: Up to End of Study (approx. 4 years)
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adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs |
Up to End of Study (approx. 4 years)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Variazione dal basale nel punteggio di disabilità della neuropatia infiammatoria corretta e del trattamento (Incat)
Lasso di tempo: Dal basale a 3 anni
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Dal basale a 3 anni
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Modifica dal basale nella scala di disabilità complessiva infiammatoria di rasch (I-RODS) nel tempo
Lasso di tempo: Dal basale a 3 anni
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Dal basale a 3 anni
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Cambia dal basale nella forza della presa (kilopascal; mano dominante) nel tempo
Lasso di tempo: Dal basale a 3 anni
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Dal basale a 3 anni
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Modifica dal basale nel punteggio del Consiglio della ricerca medica (MRC-SS) per la forza muscolare nel tempo
Lasso di tempo: Dal basale a 3 anni
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Dal basale a 3 anni
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Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)
Lasso di tempo: From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)
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To estimate the relapse-free rate, time to first relapse, defined as time from first dose of riliprubart in the parent study to the first relapse since riliprubart initiation, will be derived for each participant. Relapse since riliprubart initiation is defined as increase of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to the visit for the first dose of riliprubart in the parent study. |
From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)
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Percentage of participants experiencing improvement from baseline
Lasso di tempo: From Baseline to 3 years
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Improvement is defined as a decrease of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to baseline of the current study, Study LTS17261 |
From Baseline to 3 years
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Processi patologici
- Malattie neuromuscolari
- Malattia cronica
- Attributi della malattia
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie del sistema nervoso periferico
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Polineuropatie
- Poliradicoloneuropatia
- Condizioni patologiche, segni e sintomi
- Poliradiculoneuropatia, demielinizzante infiammatoria cronica
Altri numeri di identificazione dello studio
- LTS17261
- U1111-1311-1432 (Altro identificatore: WHO ICTRP)
- 2024-517032-22-00 (Identificatore di registro: CTIS)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .