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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions — 12 Weeks Cumulative number will be measured by magnetic resonance imaging (MRI) scans.
Trial sites (20)
Facility
City
Region
Status
Panhandle Research and Medical Clinic
Gulf Breeze
Florida
Conquest Research LLC - Winter Park - ClinEdge - PPDS
Winter Park
Florida
Consultants in Neurology
Northbrook
Illinois
Sharlin Health and Neurology
Ozark
Missouri
Premier Neurology
Greer
South Carolina
Hope Neurology
Knoxville
Tennessee
Centre Hospitalier Intercommunal - Site de Poissy
Poissy
France
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Milan
Italy
Pauls Stradins Clinical Univeristy Hospital
Riga
Latvia
Neurocentrum Bydgoszcz sp. z o.o.
Bydgoszcz
Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Katowice
Poland
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.