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

A legfontosabb adatok

Ki végzi
Sanofi
Állapot
Toborzás még nem indult
Fázis
3. fázis
Résztvevők
2500 fő, tervezett
Kezdés
2027. febr. 15.
Várható befejezés
2031. máj. 16.
A vizsgálat típusa
Beavatkozással járó, 4 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Frexalimab
  • Frexalimab Placebo
  • Teriflunomide
  • Teriflunomide Placebo
  • MRI contrast-enhancing agents
  • Cholestyramine
  • charcoal
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

Életkor
18 év – 60 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 8 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Continued need for/chronic use of a prohibited concomitant medication
  • 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
  • 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
  • If IMP discontinuation criteria are met as per guidance
  • 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
  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 60 év között vagy?

A vizsgálatról

Mit akar kideríteni a vizsgálat

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

A teljes eredeti leírásKevesebb

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.

A vizsgálat 4 csoportja

  • Frexalimab SC (OL)A vizsgált kezelés

    Participants will be administered frexalimab subcutaneous

    Kezelés: Frexalimab és MRI contrast-enhancing agents

  • Frexalimab IV (OL)A vizsgált kezelés

    Participants will be administered frexalimab intravenously

    Kezelés: Frexalimab és MRI contrast-enhancing agents

  • Frexalimab (DB)A vizsgált kezelés

    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.

    Kezelés: Frexalimab, Teriflunomide Placebo, MRI contrast-enhancing agents, Cholestyramine és charcoal

  • Teriflunomide (DB)Már használt kezelés, összehasonlításként

    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.

    Kezelés: Frexalimab Placebo, Teriflunomide, MRI contrast-enhancing agents, Cholestyramine és charcoal

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis.
Illeszkedési kérdések
Forrás: NCT07930624: ki vehet részt
A regiszteradat frissítve
2026. november 12.