This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment. The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months. The number of scheduled visits (Parts A and B) will be 17 for participants receiving frexalimab SC or IV, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Pharmaceutical form:Solution for injection-Route of administration:SC injection
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Route of administration:IV injection
North Central Neurology Associates- Site Number : 8401100
Cullman, Alabama, United States
RECRUITINGAlabama Neurology Associates- Site Number : 8400115
Homewood, Alabama, United States
RECRUITINGCenter for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195
Phoenix, Arizona, United States
RECRUITINGPerseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, United States
Area under the curve over the interval W20 to W24(part A)
AUCW20-W24
Time frame: Until Week 24
Trough concentration at steady state(part A)
Ctrough,SS
Time frame: Until Week 24
Frexalimab plasma concentrations over time (part A for IV Arm Part A, B, C for SC arm)
Time frame: Until Week 24 for IV arm, Until EOS for SC arm ( until Week 96)
Pharmacokinetic parameters: Cmax(part A)
Time frame: Until Week 24
Pharmacokinetic parameters: Tmax(part A)
Time frame: Until Week 24
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period
Time frame: Until Week 96
Incidence of ADAs over time. (part A, B and C)
Time frame: through study completion, an average of 48 weeks
Total number of Gd-enhancing T1 lesions at W12 and W24(part A)
Time frame: At Week 12 and Week 24
Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months
Time frame: Until week 96
Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study
Time frame: Until week 96
Percentage of participants that prefer SC administration over IV administration assessed by Items 13 and 14 of the PESQ at Week 48 completed by participants that switched from IV to SC in Part B.
Time frame: From week 24 to week 48
Total number of GdE T1 lesions at W48(part B)
Time frame: At week 48
Total number of GdE T1 lesions at W96 and yearly thereafter.(part C)
Time frame: At week 96 and yearly thereafter
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Private Practice - Dr. Regina Berkovich- Site Number : 8400005
West Hollywood, California, United States
RECRUITINGAdvanced Neurology of Colorado- Site Number : 8400148
Fort Collins, Colorado, United States
RECRUITINGNeurology of Central Florida- Site Number : 8400147
Altamonte Springs, Florida, United States
RECRUITINGAqualane Clinical Research- Site Number : 8400026
Naples, Florida, United States
RECRUITINGNeurology Associates of Ormond Beach- Site Number : 8400086
Ormond Beach, Florida, United States
RECRUITINGPalm Beach Neurology- Site Number : 8400105
West Palm Beach, Florida, United States
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