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New drug aims to quiet MS brain lesions

NCT ID NCT06220669

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an experimental drug called LY3541860 against a placebo in 63 adults with relapsing multiple sclerosis. The goal is to see if the drug can slow the appearance of new brain lesions seen on MRI scans. The study lasts about 9 months, with an additional 6 months of follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3541860 (an experimental drug given by IV)
What this could lead to
If it works, this could point toward a new treatment that reduces brain lesion activity in people with relapsing multiple sclerosis.
What could go wrong
This is an early Phase 2 trial with only 63 participants, so results may not apply to everyone. The drug may not slow lesions better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Centre Hospitalier Intercommunal - Site de Poissy

    Poissy, 78303, France

  • Clinirem

    Lublin, 20-064, Poland

  • Conquest Research LLC - Winter Park - ClinEdge - PPDS

    Winter Park, Florida, 32789, United States

  • Consultants in Neurology

    Northbrook, Illinois, 60062, United States

  • ETG Neuroscience - PPDS

    Warsaw, 02-677, Poland

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

    Milan, 20133, Italy

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • IBISMED Wielospecjalistyczne Centrum Medyczne

    Zabrze, 41-800, Poland

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

    Katowice, 40-571, Poland

  • NEURO-MEDIC Sp. z o. o.

    Katowice, 40-686, Poland

  • Nemocnica Ruzinov

    Bratislava, 826 06, Slovakia

  • Neurocentrum Bydgoszcz sp. z o.o.

    Bydgoszcz, 85-796, Poland

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

    Poznan, 61-853, Poland

  • Panhandle Research and Medical Clinic

    Gulf Breeze, Florida, 32561, United States

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002, Latvia

  • Premier Neurology

    Greer, South Carolina, 29605, United States

  • ProNeuro Centrum Medyczne

    Żory, 44-240, Poland

  • Queen's Medical Centre

    Nottingham, NG7 2UH, United Kingdom

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721-5315, United States

  • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

    Katowice, 40-060, Poland

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