A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

April 1, 2026 updated by: Eli Lilly and Company

An Adaptive Phase 2a/2b, Randomized, Double-Blind, Parallel-Group Study to Investigate the Safety and Efficacy of LY3541860 Compared to Placebo in Slowing the Occurrence of New T1 Gadolinium-Enhancing Lesions in Adult Participants With Relapsing Multiple Sclerosis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poissy, France, 78303
        • Centre Hospitalier Intercommunal - Site de Poissy
  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Neurocentrum Bydgoszcz sp. z o.o.
      • Katowice, Poland, 40-686
        • NEURO-MEDIC Sp. z o. o.
      • Katowice, Poland, 40-060
        • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
      • Katowice, Poland, 40-571
        • M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
      • Lublin, Poland, 20-064
        • Clinirem
      • Poznan, Poland, 61-853
        • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
      • Warsaw, Poland, 02-677
        • ETG Neuroscience - PPDS
      • Zabrze, Poland, 41-800
        • IBISMED Wielospecjalistyczne Centrum Medyczne
      • Żory, Poland, 44-240
        • ProNeuro Centrum Medyczne
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Nemocnica Ruzinov
  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre
  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Panhandle Research and Medical Clinic
      • Winter Park, Florida, United States, 32789
        • Conquest Research LLC - Winter Park - ClinEdge - PPDS
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology
    • Missouri
      • Ozark, Missouri, United States, 65721-5315
        • Sharlin Health and Neurology
    • South Carolina
      • Greer, South Carolina, United States, 29605
        • Premier Neurology
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Hope Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3541860 Phase 2a Dose Level 1
LY3541860 will be given intravenously (IV)
Drug: LY3541860
Administered IV
Experimental: LY3541860 Phase 2a Dose Level 2
LY3541860 will be given IV.
Drug: LY3541860
Administered IV
Placebo Comparator: Placebo Phase 2a
Placebo will be given IV.
Drug: Placebo
Administered IV
Experimental: LY3541860 Phase 2b Dose Level 3
LY3541860 will be given IV.
Drug: LY3541860
Administered IV
Experimental: LY3541860 Phase 2b Dose Level 4
LY3541860 will be given IV.
Drug: LY3541860
Administered IV
Placebo Comparator: Placebo Phase 2b
Placebo will be given IV.
Drug: Placebo
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Time Frame: 12 Weeks
Cumulative number will be measured by magnetic resonance imaging (MRI) scans.
12 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2024

Primary Completion (Actual)

October 18, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18548
  • J3K-MC-KIAB (Other Identifier: Eli Lilly and Company)
  • 2023-503289-22-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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