Multiple Sclerosis Clinical Trial
A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
Summary
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.
Eligibility Criteria
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:
at least 1 documented relapse within the previous year
at least 2 documented relapses within the previous 2 years, or
at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.
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:
primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2018), or
nonactive secondary progressive MS ( Klineova and Lublin 2018).
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.
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There are 41 Locations for this study
Coral Springs Florida, 33067, United States More Info
Principal Investigator
Winter Park Florida, 32789, United States More Info
Principal Investigator
Northbrook Illinois, 60062, United States More Info
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Ozark Missouri, 65721, United States More Info
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Greer South Carolina, 29605, United States More Info
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Knoxville Tennessee, 37922, United States More Info
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Seattle Washington, 98122, United States More Info
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Nancy Meurthe-et-Moselle, 54000, France More Info
Principal Investigator
Clermont-Ferrand Puy-de-Dôme, 63000, France More Info
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Poissy Yvelines, 78303, France More Info
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Böblingen Baden-Württemberg, 71034, Germany More Info
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Tübingen Baden-Württemberg, 72076, Germany More Info
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Ulm Baden-Württemberg, 89073, Germany More Info
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Bayreuth Bayern, 95445, Germany More Info
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München Bayern, 81377, Germany More Info
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Bad Homburg Hessen, 61348, Germany More Info
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Rostock Mecklenburg-Vorpommern, 18147, Germany More Info
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Münster Nordrhein-Westfalen, 48149, Germany More Info
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Leipzig Sachsen, 4103, Germany More Info
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Nahariya HaZafon, 22100, Israel More Info
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Roma Lazio, 00152, Italy More Info
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Milano Lombardia, 20132, Italy More Info
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Milano Lombardia, 20133, Italy More Info
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Cefalù Sicilia, 90015, Italy More Info
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Riga , LV-10, Latvia More Info
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Kaunas Kauno Apskritis, 50009, Lithuania More Info
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Klaipėda Klaipedos Apskritis, LT-92, Lithuania More Info
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Bydgoszcz Kujawsko-Pomorskie, 85-79, Poland More Info
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Lublin Lubelskie, 20-95, Poland More Info
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Warszawa Mazowieckie, 01-81, Poland More Info
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Czeladz Slaskie, 41-25, Poland More Info
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Katowice Slaskie, 40-06, Poland More Info
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Katowice Slaskie, 40-57, Poland More Info
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Zabrze Śląskie, 41-80, Poland More Info
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Banská Bystrica , 974 0, Slovakia More Info
Principal Investigator
Nottingham , NG7 2, United Kingdom More Info
Principal Investigator
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