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Langsiktig sikkerhet og effektivitetsstudie av Riliprubart hos deltakere med CIDP (LTS)

26. oktober 2026 oppdatert av: Sanofi

Langvarig utvidelsesstudie for å evaluere sikkerheten og effekten av Riliprubart (SAR445088) hos deltakere med kronisk inflammatorisk demyeliniserende polyneuropati (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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1221
        • Investigational Site Number : 0320003
  • Brasil
      • São Paulo, Brasil, 04038-002
        • PSEG Centro de Pesquisa Clínica- Site Number : 0760009
    • Federal District
      • Brasília, Federal District, Brasil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Investigational Site Number : 1000002
  • Canada
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 1W2
        • Investigational Site Number : 1240001
      • Québec, Quebec, Canada, G1E 7G9
        • Investigational Site Number : 1240002
  • Chile
    • Reg Metropolitana de Santiago
      • Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
        • Investigational Site Number : 1520003
      • Puente Alto, Reg Metropolitana de Santiago, Chile, 8207257
        • Investigational Site Number : 1520002
  • Danmark
      • Aarhus, Danmark, 8200
        • Investigational Site Number : 2080002
      • Copenhagen, Danmark, 2100
        • Investigational Site Number : 2080001
  • Forente stater
    • Alabama
      • Homewood, Alabama, Forente stater, 35209
        • Alabama Neurology Associates- Site Number : 8400019
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85251
        • Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Medical Center- Site Number : 8400010
    • New York
      • New York, New York, Forente stater, 10032
        • Columbia University Irving Medical Center- Site Number : 8400003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Investigational Site Number : 2500007
      • Le Kremlin-Bicêtre, Frankrike, 94270
        • Investigational Site Number : 2500001
      • Marseille, Frankrike, 13885
        • Investigational Site Number : 2500002
      • Montpellier, Frankrike, 34090
        • Investigational Site Number : 2500005
      • Paris, Frankrike, 75013
        • Investigational Site Number : 2500004
  • Italia
      • Pavia, Italia, 27100
        • Investigational Site Number : 3800005
      • Pisa, Italia, 56126
        • Investigational Site Number : 3800007
    • Genova
      • Genoa, Genova, Italia, 16132
        • Investigational Site Number : 3800003
    • Milano
      • Milan, Milano, Italia, 20132
        • Investigational Site Number : 3800001
      • Rozzano, Milano, Italia, 20089
        • Investigational Site Number : 3800004
    • Roma
      • Rome, Roma, Italia, 00168
        • Investigational Site Number : 3800002
  • Japan
    • Saitama
      • Higashi-Matsuyama, Saitama, Japan, 355-0005
        • Investigational Site Number : 3920012
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8510
        • Investigational Site Number : 3920011
      • Kodaira, Tokyo, Japan, 187-8551
        • Investigational Site Number : 3920008
  • Kina
      • Beijing, Kina, 100034
        • Investigational Site Number : 1560013
      • Beijing, Kina, 100053
        • Investigational Site Number : 1560005
      • Changsha, Kina, 410008
        • Investigational Site Number : 1560009
      • Chengdu, Kina, 610072
        • Investigational Site Number : 1560011
      • Fuzhou, Kina, 350001
        • Investigational Site Number : 1560002
      • Guangzhou, Kina, 510000
        • Investigational Site Number : 1560012
      • Hangzhou, Kina, 310009
        • Investigational Site Number : 1560014
      • Shanghai, Kina, 200040
        • Investigational Site Number : 1560001
      • Wuhan, Kina, 430030
        • Investigational Site Number : 1560003
      • Wuhan, Kina, 430060
        • Investigational Site Number : 1560006
      • Xi'an, Kina, 710038
        • Investigational Site Number : 1560004
  • Mexico
      • Tlalnepantla, Mexico, 54055
        • Investigational Site Number : 4840001
  • Nederland
      • Amsterdam, Nederland, 1105 AZ
        • Investigational Site Number : 5280001
  • Polen
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-954
        • Investigational Site Number : 6160001
  • Portugal
      • Lisbon, Portugal, 1150-199
        • Investigational Site Number : 6200004
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigational Site Number : 6880001
  • Spania
      • Málaga, Spania, 29010
        • Investigational Site Number : 7240008
      • Valencia, Spania, 46026
        • Investigational Site Number : 7240003
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spania, 08041
        • Investigational Site Number : 7240001
      • Barcelona, Catalunya [Cataluña], Spania, 08035
        • Investigational Site Number : 7240002
    • Madrid
      • Majadahonda, Madrid, Spania, 28222
        • Investigational Site Number : 7240004
    • Navarre
      • Pamplona, Navarre, Spania, 31008
        • Investigational Site Number : 7240006
  • Storbritannia
    • Oxfordshire
      • Oxford, Oxfordshire, Storbritannia, OX3 9DU
        • Investigational Site Number : 8260001
  • Sverige
      • Stockholm, Sverige, 113 65
        • Investigational Site Number : 7520001
  • Sør -Korea
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Sør -Korea, 02841
        • Investigational Site Number : 4100003
  • Taiwan
      • Taipei, Taiwan, 100
        • Investigational Site Number : 1580001
  • Tsjekkia
      • Brno, Tsjekkia, 625 00
        • Investigational Site Number : 2030004
      • Prague, Tsjekkia, 128 08
        • Investigational Site Number : 2030001
  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34093
        • Investigational Site Number : 7920001
      • Konya, Tyrkia (Türkiye), 42075
        • Investigational Site Number : 7920003
  • Tyskland
      • Göttingen, Tyskland, 37075
        • Investigational Site Number : 2760002
      • Münster, Tyskland, 48149
        • Investigational Site Number : 2760003
      • Tübingen, Tyskland, 72076
        • Investigational Site Number : 2760004

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: riliprubart

Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)
Legemiddel: Riliprubart Prefilled Pen (PFP)

Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Andre navn:
  • SAR445088

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: Up to End of Study (approx. 4 years)

adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs
Up to End of Study (approx. 4 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i justert inflammatorisk nevropati Årsak og behandling (Incat) funksjonshemming over tid
Tidsramme: Fra baseline til 3 år
Fra baseline til 3 år
Endring fra baseline i inflammatorisk Rasch-bygget total funksjonshemming (I-Rods) over tid
Tidsramme: Fra baseline til 3 år
Fra baseline til 3 år
Endring fra baseline i grepstyrke (Kilopascals; Dominant Hand) over tid
Tidsramme: Fra baseline til 3 år
Fra baseline til 3 år
Endring fra baseline i Medical Research Council-Sum Score (MRC-SS) for muskelstyrke over tid
Tidsramme: Fra baseline til 3 år
Fra baseline til 3 år
Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)
Tidsramme: From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)

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)
Percentage of participants experiencing improvement from baseline
Tidsramme: From Baseline to 3 years

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2025

Primær fullføring (Antatt)

3. oktober 2029

Studiet fullført (Antatt)

3. oktober 2029

Datoer for studieregistrering

Først innsendt

27. februar 2025

Først innsendt som oppfylte QC-kriteriene

27. februar 2025

Først lagt ut (Faktiske)

5. mars 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LTS17261
  • U1111-1311-1432 (Annen identifikator: WHO ICTRP)
  • 2024-517032-22-00 (Registeridentifikator: CTIS)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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