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Clinical Trials in the USA / NCT06220669
Active, not recruiting Phase 2

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

NCT06220669 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2024-03-19
Last updated
2026-04-07

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

LY3541860Placebo

LY3541860: Administered IV

Placebo: Administered IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Panhandle Research and Medical Clinic Gulf Breeze Florida
Conquest Research LLC - Winter Park - ClinEdge - PPDS Winter Park Florida
Consultants in Neurology Northbrook Illinois
Sharlin Health and Neurology Ozark Missouri
Premier Neurology Greer South Carolina
Hope Neurology Knoxville Tennessee
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

More Eli Lilly and Company trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220669 on ClinicalTrials.gov ↗ ← All trials in the USA