A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Phase 2

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: LY3541860; Drug: Placebo

• Registration Number: NCT06220669
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Study Start: 2024-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3541860 Phase 2a Dose Level 1	LY3541860	LY3541860 will be given intravenously (IV)
LY3541860 Phase 2b Dose Level 3	LY3541860	LY3541860 will be given IV.
LY3541860 Phase 2a Dose Level 2	LY3541860	LY3541860 will be given IV.
LY3541860 Phase 2b Dose Level 4	LY3541860	LY3541860 will be given IV.
Placebo Phase 2a	Placebo	Placebo will be given IV.
Placebo Phase 2b	Placebo	Placebo will be given IV.

Primary Outcome Measures

Name	Time	Method
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions	12 Weeks	Cumulative number will be measured by magnetic resonance imaging (MRI) scans.

Secondary Outcome Measures

Name	Time	Method
Cumulative Number of New and/or Enlarging T2 Lesions	12 Weeks	Cumulative number will be measured by MRI scans.
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860	Baseline Through Week 12	Plasma trough concentrations of LY3541860 was measured.
Cumulative Number of Total Number of T1 GdE Lesions	12 Weeks	Cumulative number will be measured by MRI scans.

Trial Locations

Locations (54)

Universitatsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Healthcare Innovations Institute, LLC; 🇺🇸 Coral Springs, Florida, United States

Royal Palm Medical Group; 🇺🇸 Fort Myers, Florida, United States

Eastern Medical Group Research; 🇺🇸 Fort Myers, Florida, United States

Panhandle Research and Medical Clinic; 🇺🇸 Pensacola, Florida, United States

USF MS Center; 🇺🇸 Tampa, Florida, United States

Conquest Research LLC - Winter Park - ClinEdge - PPDS; 🇺🇸 Winter Park, Florida, United States

Consultants in Neurology; 🇺🇸 Northbrook, Illinois, United States

Sharlin Health and Neurology; 🇺🇸 Ozark, Missouri, United States

Psych Care Consultants Research; 🇺🇸 Saint Louis, Missouri, United States

Premier Neurology; 🇺🇸 Greer, South Carolina, United States

Hope Neurology; 🇺🇸 Knoxville, Tennessee, United States

ANRC Research; 🇺🇸 El Paso, Texas, United States

Prolato Clinical Research Center; 🇺🇸 Houston, Texas, United States

1960 Family Practice, PA; 🇺🇸 Houston, Texas, United States

Swedish Multiple Sclerosis Center; 🇺🇸 Seattle, Washington, United States

CHU Gui De Chauliac; 🇫🇷 Nîmes, Gard, France

CHRU de Nancy; 🇫🇷 Nancy, Meurthe-et-Moselle, France

Centre Hospitalier Universitaire de Clermont Ferrand; 🇫🇷 Clermont-Ferrand, Puy-de-Dôme, France

Centre Hospitalier Intercommunal - Site de Poissy; 🇫🇷 Poissy, Yvelines, France

Studienzentrum für Neurologie und Psychiatrie; 🇩🇪 Böblingen, Baden-Württemberg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Nervenfachärztliche Gemeinschaftspraxis Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Klinikum Bayreuth GmbH; 🇩🇪 Bayreuth, Bayern, Germany

Institut für klinische Neuroimmunologie LMU Muenchen; 🇩🇪 München, Bayern, Germany

Zentrum für klinische Forschung Dr. med. Irma Schöll; 🇩🇪 Bad Homburg, Hessen, Germany

Universitätsklinik Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Kaplan Medical Center; 🇮🇱 Rehovot, HaMerkaz, Israel

Galilee Medical Center; 🇮🇱 Nahariya, HaZafon, Israel

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Roma, Lazio, Italy

Ospedale San Raffaele S.r.l. - PPDS; 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3; 🇮🇹 Milano, Lombardia, Italy

Fondazione Istituto G. Giglio di Cefalù; 🇮🇹 Cefalù, Sicilia, Italy

Pauls Stradins Clinical Univeristy Hospital; 🇱🇻 Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kaunas Clinics; 🇱🇹 Kaunas, Kauno Apskritis, Lithuania

Klaipeda Hospital, Affiliate of Klaipeda University Hospital; 🇱🇹 Klaipėda, Klaipedos Apskritis, Lithuania

Neurocentrum Bydgoszcz sp. z o.o.; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland

Clinirem; 🇵🇱 Lublin, Lubelskie, Poland

Centrum Medyczne NeuroProtect; 🇵🇱 Warszawa, Mazowieckie, Poland

ETG Neuroscience - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

Neurosphera SP. Z O.O; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Medyczne PRO Femina; 🇵🇱 Czeladz, Slaskie, Poland

Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala; 🇵🇱 Katowice, Slaskie, Poland

M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM; 🇵🇱 Katowice, Slaskie, Poland

Med-Polonia Sp. z o.o.; 🇵🇱 Poznan, Wielkopolskie, Poland

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy; 🇵🇱 Poznan, Wielkopolskie, Poland

NEURO-MEDIC Sp. z o. o.; 🇵🇱 Katowice, Poland

ProNeuro Centrum Medyczne; 🇵🇱 Żory, Poland

IBISMED Wielospecjalistyczne Centrum Medyczne; 🇵🇱 Zabrze, Śląskie, Poland

Neurologicka Ambulancia s.r.o.; 🇸🇰 Banská Bystrica, Slovakia

Nemocnica Ruzinov; 🇸🇰 Bratislava, Slovakia

Queen's Medical Centre; 🇬🇧 Nottingham, United Kingdom