A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06220669

Run by

Eli Lilly and Company

People needed

63

Starts

2024-03-19

Expected to finish

2026-07-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Panhandle Research and Medical Clinic — Gulf Breeze, 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
• Premier Neurology — Greer, South Carolina, United States
• Hope Neurology — Knoxville, Tennessee, United States
• Centre Hospitalier Intercommunal - Site de Poissy — Poissy, France
• Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3 — Milan, Italy
• Pauls Stradins Clinical Univeristy Hospital — Riga, Latvia
• Neurocentrum Bydgoszcz sp. z o.o. — Bydgoszcz, Poland
• Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala — Katowice, Poland
• M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM — Katowice, Poland
• NEURO-MEDIC Sp. z o. o. — Katowice, Poland
• Clinirem — Lublin, Poland
• Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy — Poznan, Poland
• ETG Neuroscience - PPDS — Warsaw, Poland
• IBISMED Wielospecjalistyczne Centrum Medyczne — Zabrze, Poland
• ProNeuro Centrum Medyczne — Żory, Poland
• Nemocnica Ruzinov — Bratislava, Slovakia
• Queen's Medical Centre — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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