A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

LY3541860

Placebo

Clinical Study ID

NCT06220669
18548
2023-503289-22-00
J3K-MC-KIAB
  • Ages 18-55
  • All Genders

Study 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

Inclusion Criteria:

  • Participants must meet criteria for relapsing forms of multiple sclerosis, includingrelapsing-remitting multiple sclerosis based on the 2017 revision of the McDonalddiagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activityaccording 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 toscreening.

  • Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.

Exclusion

Exclusion Criteria:

  • Have had a diagnosis of:

  • primary progressive multiple sclerosis (MS) according to the 2017 revision ofMcDonald 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 daysprior 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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: LY3541860
Phase: 2
Study Start date:
March 19, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • CHU Gui De Chauliac

    Nîmes, Gard 30029
    France

    Site Not Available

  • CHRU de Nancy

    Nancy, Meurthe-et-Moselle 54000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, Puy-de-Dôme 63000
    France

    Site Not Available

  • Centre Hospitalier Intercommunal - Site de Poissy

    Poissy, Yvelines 78303
    France

    Active - Recruiting

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, Baden-Württemberg 71034
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • Nervenfachärztliche Gemeinschaftspraxis Ulm

    Ulm, Baden-Württemberg 89073
    Germany

    Site Not Available

  • Klinikum Bayreuth GmbH

    Bayreuth, Bayern 95445
    Germany

    Site Not Available

  • Institut für klinische Neuroimmunologie LMU Muenchen

    München, Bayern 81377
    Germany

    Site Not Available

  • Klinikum Großhadern, LMU

    München, Bayern 81377
    Germany

    Site Not Available

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, Hessen 61348
    Germany

    Site Not Available

  • Universitätsklinik Rostock

    Rostock, Mecklenburg-Vorpommern 18147
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, Sachsen 4103
    Germany

    Site Not Available

  • Kaplan Medical Center

    Rehovot, HaMerkaz 76100
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, HaZafon 22100
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78278
    Israel

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, Lazio 00152
    Italy

    Site Not Available

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Fondazione Istituto G. Giglio di Cefalù

    Cefalù, Sicilia 90015
    Italy

    Site Not Available

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, Kauno Apskritis 50009
    Lithuania

    Site Not Available

  • Klaipeda Hospital, Affiliate of Klaipeda University Hospital

    Klaipėda, Klaipedos Apskritis LT-92288
    Lithuania

    Site Not Available

  • Neurocentrum Bydgoszcz sp. z o.o.

    Bydgoszcz, Kujawsko-Pomorskie 85-796
    Poland

    Active - Recruiting

  • Clinirem

    Lublin, Lubelskie 20-064
    Poland

    Active - Recruiting

  • Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz

    Lublin, Lubelskie 20-954
    Poland

    Active - Recruiting

  • Centrum Medyczne NeuroProtect

    Warszawa, Mazowieckie 01-684
    Poland

    Site Not Available

  • ETG Neuroscience - PPDS

    Warszawa, Mazowieckie 02-677
    Poland

    Site Not Available

  • Neurosphera SP. Z O.O

    Warszawa, Mazowieckie 02-952
    Poland

    Site Not Available

  • Centrum Medyczne PRO Femina

    Czeladz, Slaskie 41-250
    Poland

    Site Not Available

  • M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM

    Katowice, Slaskie 40-571
    Poland

    Active - Recruiting

  • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

    Katowice, Slaskie 40-060
    Poland

    Site Not Available

  • Med-Polonia Sp. z o.o.

    Poznan, Wielkopolskie 60-693
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

    Poznan, Wielkopolskie 61-853
    Poland

    Site Not Available

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, Śląskie 41-800
    Poland

    Active - Recruiting

  • NEURO-MEDIC Sp. z o. o.

    Katowice, 40-686
    Poland

    Site Not Available

  • ProNeuro Centrum Medyczne

    Żory, 44-240
    Poland

    Site Not Available

  • Neurologicka Ambulancia s.r.o.

    Banská Bystrica, 974 04
    Slovakia

    Site Not Available

  • Nemocnica Ruzinov

    Bratislava, 826 06
    Slovakia

    Active - Recruiting

  • Queen's Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • Panhandle Research and Medical Clinic

    Pensacola, Florida 32502
    United States

    Active - Recruiting

  • USF MS Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Conquest Research LLC - Winter Park - ClinEdge - PPDS

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Consultants in Neurology

    Northbrook, Illinois 60062
    United States

    Active - Recruiting

  • Sharlin Health and Neurology

    Ozark, Missouri 65721-5315
    United States

    Active - Recruiting

  • Premier Neurology

    Greer, South Carolina 29605
    United States

    Active - Recruiting

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • ANRC Research

    El Paso, Texas 79912-1743
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054-2852
    United States

    Site Not Available

  • Swedish Multiple Sclerosis Center

    Seattle, Washington 98122
    United States

    Site Not Available

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