A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Last updated: December 8, 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

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, Puy-de-Dôme 63000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand 3024635, 63000
    France

    Site Not Available

  • CHRU de Nancy

    Nancy, 54000
    France

    Site Not Available

  • CHRU de Nancy

    Nancy 2990999, 54000
    France

    Site Not Available

  • CHU Gui De Chauliac

    Nîmes, 30029
    France

    Site Not Available

  • CHU Gui De Chauliac

    Nîmes 2990363, 30029
    France

    Site Not Available

  • Centre Hospitalier Intercommunal - Site de Poissy

    Poissy, 78303
    France

    Site Not Available

  • Centre Hospitalier Intercommunal - Site de Poissy

    Poissy 2986501, 78303
    France

    Active - Recruiting

  • Klinikum Großhadern, LMU

    München, Bayern 81377
    Germany

    Site Not Available

  • Universitätsklinik Rostock

    Rostock, Mecklenburg-Vorpommern 18147
    Germany

    Site Not Available

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348
    Germany

    Site Not Available

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg 2953436, 61348
    Germany

    Site Not Available

  • Klinikum Bayreuth GmbH

    Bayreuth, 95445
    Germany

    Site Not Available

  • Klinikum Bayreuth GmbH

    Bayreuth 2951825, 95445
    Germany

    Site Not Available

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, 71034
    Germany

    Site Not Available

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen 2947444, 71034
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, 4103
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig 2879139, 4103
    Germany

    Site Not Available

  • Institut für klinische Neuroimmunologie LMU Muenchen

    München, 81377
    Germany

    Site Not Available

  • Institut für klinische Neuroimmunologie LMU Muenchen

    München 2867711, 81377
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster 2867543, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Nervenfachärztliche Gemeinschaftspraxis Ulm

    Ulm, 89073
    Germany

    Site Not Available

  • Nervenfachärztliche Gemeinschaftspraxis Ulm

    Ulm 2820256, 89073
    Germany

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 78278
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya 294117, 22100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 76100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot 293725, 76100
    Israel

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, Lazio 00152
    Italy

    Site Not Available

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

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Fondazione Istituto G. Giglio di Cefalù

    Cefalù, 90015
    Italy

    Site Not Available

  • Fondazione Istituto G. Giglio di Cefalù

    Cefalù 2525041, 90015
    Italy

    Site Not Available

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

    Milan 6951411, 20133
    Italy

    Active - Recruiting

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

    Milan 6951411, 20132
    Italy

    Site Not Available

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

    Milano, 20133
    Italy

    Site Not Available

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • Pauls Stradins Clinical Univeristy Hospital

    Riga 456172, LV-1002
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas 598316, 50009
    Lithuania

    Site Not Available

  • Klaipeda Hospital, Affiliate of Klaipeda University Hospital

    Klaipėda, LT-92288
    Lithuania

    Site Not Available

  • Klaipeda Hospital, Affiliate of Klaipeda University Hospital

    Klaipėda 598098, LT-92288
    Lithuania

    Site Not Available

  • 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

  • Centrum Medyczne PRO Femina

    Czeladz, Slaskie 41-250
    Poland

    Site Not Available

  • 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

  • Neurocentrum Bydgoszcz sp. z o.o.

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • Neurocentrum Bydgoszcz sp. z o.o.

    Bydgoszcz 3102014, 85-796
    Poland

    Active - Recruiting

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

    Katowice, 40-571
    Poland

    Site Not Available

  • NEURO-MEDIC Sp. z o. o.

    Katowice, 40-686
    Poland

    Site Not Available

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

    Katowice 3096472, 40-571
    Poland

    Active - Recruiting

  • NEURO-MEDIC Sp. z o. o.

    Katowice 3096472, 40-686
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

    Katowice 3096472, 40-060
    Poland

    Site Not Available

  • Clinirem

    Lublin, 20-064
    Poland

    Site Not Available

  • Clinirem

    Lublin 765876, 20-064
    Poland

    Active - Recruiting

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

    Poznan, 61-853
    Poland

    Site Not Available

  • Med-Polonia Sp. z o.o.

    Poznan 3088171, 60-693
    Poland

    Site Not Available

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

    Poznan 3088171, 61-853
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warsaw 756135, 01-684
    Poland

    Site Not Available

  • ETG Neuroscience - PPDS

    Warsaw 756135, 02-677
    Poland

    Site Not Available

  • Neurosphera SP. Z O.O

    Warsaw 756135, 02-952
    Poland

    Site Not Available

  • Neurosphera SP. Z O.O

    Warszawa, 02-952
    Poland

    Site Not Available

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800
    Poland

    Site Not Available

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze 3080985, 41-800
    Poland

    Active - Recruiting

  • ProNeuro Centrum Medyczne

    Żory, 44-240
    Poland

    Site Not Available

  • ProNeuro Centrum Medyczne

    Żory 3080004, 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

    Site Not Available

  • Nemocnica Ruzinov

    Bratislava 3060972, 826 06
    Slovakia

    Active - Recruiting

  • Queen's Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Queen's Medical Centre

    Nottingham 2641170, NG7 2UH
    United Kingdom

    Suspended

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Eastern Medical Group Research

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Royal Palm Medical Group

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • High Quality Research

    Miami, Florida 33184-1412
    United States

    Site Not Available

  • Panhandle Research and Medical Clinic

    Pensacola, Florida 32502
    United States

    Site Not Available

  • USF MS Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Conquest Research LLC - Winter Park - ClinEdge - PPDS

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Healthcare Innovations Institute, LLC

    Coral Springs 4151909, Florida 4155751 33067
    United States

    Site Not Available

  • Eastern Medical Group Research

    Fort Myers 4155995, Florida 4155751 33908
    United States

    Site Not Available

  • Royal Palm Medical Group

    Fort Myers 4155995, Florida 4155751 33901
    United States

    Site Not Available

  • Panhandle Research and Medical Clinic

    Gulf Breeze 4157634, Florida 4155751 32561
    United States

    Active - Recruiting

  • High Quality Research

    Miami 4164138, Florida 4155751 33184-1412
    United States

    Site Not Available

  • Panhandle Research and Medical Clinic

    Pensacola 4168228, Florida 4155751 32502
    United States

    Site Not Available

  • USF MS Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Conquest Research LLC - Winter Park - ClinEdge - PPDS

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Consultants In Neurology

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Consultants in Neurology

    Northbrook 4904056, Illinois 4896861 60062
    United States

    Active - Recruiting

  • Sharlin Health and Neurology

    Ozark, Missouri 65721-5315
    United States

    Site Not Available

  • Psych Care Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Sharlin Health and Neurology

    Ozark 4402245, Missouri 4398678 65721-5315
    United States

    Active - Recruiting

  • Psych Care Consultants Research

    St Louis 4407066, Missouri 4398678 63128
    United States

    Site Not Available

  • Premier Neurology

    Greer, South Carolina 29605
    United States

    Site Not Available

  • Premier Neurology

    Greer 4580599, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Hope Neurology

    Knoxville 4634946, Tennessee 4662168 37922
    United States

    Active - Recruiting

  • ANRC Research

    El Paso, Texas 79912-1743
    United States

    Site Not Available

  • 1960 Family Practice, PA

    Houston, Texas 77079
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054-2852
    United States

    Site Not Available

  • ANRC Research

    El Paso 5520993, Texas 4736286 79912-1743
    United States

    Site Not Available

  • 1960 Family Practice, PA

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston 4699066, Texas 4736286 77054-2852
    United States

    Site Not Available

  • Swedish Multiple Sclerosis Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Multiple Sclerosis Center

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

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