Active — Not RecruitingPhase 2

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

United States, France, Italy63 participantsStarted 2024-03-19

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 abnormali…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

Timeframe: 12 Weeks

Trial details

NCT IDNCT06220669

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-18

View on ClinicalTrials.gov More Multiple Sclerosis trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.