Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis

10 novembre 2026 aggiornato da: Sanofi

A Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis.

Study LTS18002 is a global, multicenter, open-label (OL), Phase 3, long-term safety and efficacy extension study.

The purpose of this study is to provide continued access to frexalimab for participants with MS, and to evaluate the long-term safety and efficacy profile of frexalimab. This study will monitor delayed AEs, assess the durability of safety findings and characterize any emerging safety signals that may develop over an extended follow up period.

Study details include:

  • The study duration will be up to 4 years.

  • The OL treatment duration will be up to 96 weeks (corresponding to approximately 2 years) per participant.

  • There is an additional 24 weeks of safety follow up from the last dose of OL frexalimab for all participants (safety follow-up period/EOS: 4, 12 and 24 weeks after last investigational medicinal product(IMP) or OL frexalimab administration).

  • The number of visits over the 2-year duration will be dependent on subgroup assignment which is based on parent study from which the participant has entered the LTS18002 :

    1. ACT16877, EFC17504, EFC18098, and ASY22814 participants

      • Will have on-site visits every 12 weeks (9 visits)

        • Additionally, there will be 16 on-site visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92) for all participants EXCEPT those entering from EFC18098 (frexalimab open label administration is conducted at home via SC large volume (OBDS VT) device)

          • There will be 3 follow up visits beginning 4 weeks after the last administration of OL frexalimab

            • Home administration is allowed for participants from ACT16877, based on Investigator judgement, participant/caregiver training and local availability. Home nurse services are mandatory for at-home administration.

              • Home nurse services for at home administration may be considered for EFC17504 participants after Week 24 administration of OL frexalimab, based on availability. Participants that have initiated OL frexalimab via home administration during the parent study may continue to receive it in this manner.

                • NOTE: For participants from EFC17504, all on-site visits including monthly IMP administrations will include safety labs (biochemistry, hematology liver chemistry, and immunoglobulins) and physical exams

    2. EFC17919A/B participants

      • Will have on site visits every 12 weeks (9 visits)

        • Will have a total of 16 visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92)

          • Additionally, there will be up to 3 visits for administration of DB treatment (until results become available and randomization assignment availability).

            • Home nurse services for at home administration may be considered for EFC17919A/B participants after Week 24 administration of OL frexalimab, based on availability.

NOTE: all on-site visits including monthly IMP administrations will include safety labs (biochemistry, hematology liver chemistry, and immunoglobulins) and physical exams.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

2500

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Numero di telefono: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

- Participants with relapsing multiple sclerosis(RMS) or non-relapsing secondary progressive multiple sclerosis(nrSPMS) who completed, on IMP, the Phase 2 ACT16877 study, or one of the four Phase 3 frexalimab studies in MS indication (EFC17919A and EFC17919B, EFC17504, EFC18098), or planned Phase 2 biomarker ASY22814.

Exclusion Criteria:

  • If IMP discontinuation criteria are met as per guidance
  • The participant is at risk for or has a persistent chronic, active (including fever ≥38°C and clinically unstable), recurring systemic infection or opportunistic infections (eg, PML See Appendix in protocol) as judged by the Investigator.
  • Notably low immunoglobulin G(IgG) levels, defined as a level that is 20% below the LLN, and/or notably low IgM level, defined as a level 10% below the LLN.
  • Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the extension study, as judged by the Investigator.
  • Clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
  • Continued need for/chronic use of a prohibited concomitant medication.
  • Suicidal risk as per C-SSRS: if a participant scores "yes" on items 4 or 5 of the Suicidal Ideation Section, or "yes" on any item of the Suicidal Behavior Section.

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Frexalimab SC (OL)

Participants will be administered frexalimab subcutaneous
Droga: Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC

Altri nomi:
  • SAR441344
Droga: Frexalimab

Pharmaceutical form:Solution for infusion-Route of administration:IV

Altri nomi:
  • SAR441344
Droga: MRI contrast-enhancing agents

Route of administration:IV
Sperimentale: Frexalimab IV (OL)

Participants will be administered frexalimab intravenously
Droga: Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC

Altri nomi:
  • SAR441344
Droga: Frexalimab

Pharmaceutical form:Solution for infusion-Route of administration:IV

Altri nomi:
  • SAR441344
Droga: MRI contrast-enhancing agents

Route of administration:IV
Sperimentale: Frexalimab (DB)

For EFC17919A/B parent study participants: at Opt-in visit participants will continue to be administered f rexalimab through unblinding visit. Participants will receive placebo tablet once daily until the unblinding visit.
Droga: Frexalimab

Pharmaceutical form:Solution for injection-Route of administration:SC

Altri nomi:
  • SAR441344
Droga: Frexalimab

Pharmaceutical form:Solution for infusion-Route of administration:IV

Altri nomi:
  • SAR441344
Droga: MRI contrast-enhancing agents

Route of administration:IV

Droga: Teriflunomide Placebo

Pharmaceutical form:Tablet-Route of administration:Oral

Droga: Cholestyramine

Route of administration:oral

Droga: charcoal

Route of administration:oral
Comparatore attivo: Teriflunomide (DB)

For EFC17919A/B parent study participants: at Opt-in visit participants will continue to receive teriflunomide tablet. The placebo will be administered to participants at the same infusion rate and duration as for frexalimab from the opt-in visit until availability of results and unblinding.
Droga: MRI contrast-enhancing agents

Route of administration:IV

Droga: Cholestyramine

Route of administration:oral

Droga: charcoal

Route of administration:oral

Droga: Frexalimab Placebo

Pharmaceutical form:Solution for infusion-Route of administration:IV

Droga: Teriflunomide

Pharmaceutical form:Tablet-Route of administration:Oral

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with Adverse Events(AEs)
Lasso di tempo: up to to approximately 2.5 years since last participant in

Number of participants with Adverse Events(AEs), serious adverse event(SAEs), AEs leading to permanent study intervention discontinuation, adverse event of special interest(AESIs), local tolerability, clinically significant abnormalities in laboratory tests, Columbia-Suicide Severity Rating Scale(C-SSRS)
up to to approximately 2.5 years since last participant in

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants from EFC17919A, EFC17919B, and EFC17504 studies only: time to onset of 6-month composite confirmed disability worsening(cCDW) for RMS or composite confirmed disability progression(cCDP) for nrSPMS
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
Time to onset of individual components of the composite, confirmed over 3 months or 6 months EDSS for all prior study participants 9-HPT, T25FW test (participants rolling over from EFC17504, EFC17919A, and EFC17919B)
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
Progression independent of relapse activity defined as the time to onset of 6-month cCDW
Lasso di tempo: up to to approximately 2.5 years since last participant in

Progression independent of relapse activity defined as the time to onset of 6-month cCDW, defined by either no prior relapse or an onset more than 90 days after the start date of the last Investigator reported relapse (participants rolling over from EFC17919A and EFC17919B)
up to to approximately 2.5 years since last participant in
Number of new and/or enlarging T2-hyperintense lesions per year as detected by MRI
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
Total number of new GdE T1 lesions per year as detected by MRI
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
Change from baseline at scheduled visits in total volume of T2-hyperintense lesions as detected by brain MRI
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
ARR assessed by confirmed protocol defined relapses
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
antidrug antibodys(ADAs) incidence
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in
Change from baseline in serum immunoglobulin(Ig) levels
Lasso di tempo: up to to approximately 2.5 years since last participant in
up to to approximately 2.5 years since last participant in

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 febbraio 2027

Completamento primario (Stimato)

16 maggio 2031

Completamento dello studio (Stimato)

16 maggio 2031

Date di iscrizione allo studio

Primo inviato

3 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LTS18002
  • 2026-525688-41 (Identificatore di registro: CTIS)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

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

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

Sottoscrivi