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. 2024 Nov 12;86(12):7305–7313. doi: 10.1097/MS9.0000000000002745

Table 3.

The table shows the regimen, primary outcomes, and major secondary outcomes of all the clinical trials of Frexalimab for treating multiple sclerosis

ClinicalTrials.gov ID Regimen of frexalimab Primary outcome Secondary outcomes
NCT06141486 IV Frexalimab Time to onset of cCDP (6 months) Time to onset of cCDP (3 months), Time to onset of CDI, Number of new/enlarging T2 lesions, Percent change in brain volume, change in cognitive function, Change in MSIS-29v2 scores, Change in PROMIS Fatigue MS-8a, Annualized relapse rate, Adverse events, Laboratory/ECG/vital sign abnormalities, Antibody levels, change in serum Ig, Change in NfL levels, frexalimab plasma concentration
NCT06141473 IV frexalimab Annualized relapse rate (ARR) Time to onset of cCDW (3 and 6 months), time to onset of CDI, progression independent of relapse activity, number of new/enlarging T2 lesions, number of new Gd-enhancing T1 lesions, percent change in brain volume, change in cognitive function, Change in MSIS-29v2 scores, change in PROMIS fatigue MS-8, adverse events, laboratory/ECG/vital sign abnormalities, Antidrug antibodies, Change in NfL levels, Frexalimab plasma concentration
NCT04879628 1200 mg IV frexalimab, 300 mg SC frexalimab Number of new Gd-enhancing T1 lesions Number of new/enlarging T2 lesions, Total number of Gd-enhancing T1 lesions, adverse events, antidrug antibodies, pharmacokinetics (Cmax, tmax, AUC0-tau, t1/2z)