LTS18002
What it found
No result yet.
What was tested
Treatment tested
- Frexalimab
Compared with
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
Placebo or sham
- Matched placebo for comparator teriflunomide
- Matched placebo for test product frexalimab
What it measured
Main measures
Number of participants with AEs, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, local tolerability, clinically significant abnormalities in laboratory tests, Columbia-Suicide Severity Rating Scale(C SSRS)
Safety
Other measures (9)
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)
Disability progressionTime 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)
Disability progressionProgression 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)
Disability progressionRelapsesNumber of new and/or enlarging T2-hyperintense lesions per year as detected by MRI
MRI lesionsTotal number of new GdE T1 lesions per year as detected by MRI
MRI lesionsChange from baseline at scheduled visits in total volume of T2 hyperintense lesions as detected by brain MRI
MRI lesionsARR assessed by confirmed protocol defined relapses
RelapsesADAs incidence
Change from baseline in serum Ig levels
Who could take part
Relapsing MS · 18 to 64
Inclusion: - Participants with RMS or 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. - All Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - The participant must be capable of giving signed informed consent Exclusion: - If IMP discontinuation criteria are met as per guidance - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. - 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 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. - The participant is no longer deriving a therapeutic/clinical benefit in the opinion of the Investigator - 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. - Continued need for/chronic use of a prohibited concomitant medication - Any country-related specific regulation that would prevent the participant from entering
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
To determine the long-term safety and tolerability of frexalimab IV and SC administrations
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History
- Enrollment changed from 29 to 37
Started
Feb 2027
Finished
Jan 2030
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