Consultants in Neurology, Ltd. | Northbrook, IL
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About
The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better. The study will last about 9 months with additional 6 months follow-up.
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Inclusion criteria
Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lublin 2018.
Participants must have 1 of these:
Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.
Exclusion criteria
Have had a diagnosis of:
Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
Have a history of clinically significant central nervous system (CNS) disease.
Have had a confirmed relapse with systemic corticosteroid administration <30 days prior to randomization.
Have more than 20 active GdE brain lesions on screening MRI scan.
Have received any of these medications or treatments.
Have a current or recent acute, active infection.
Have current serious or unstable illnesses.
Have any other clinically important abnormality at screening or baseline.
Primary purpose
Allocation
Interventional model
Masking
200 participants in 6 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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