RecruitingPhase 2NCT06220669

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

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

Sponsor

Eli Lilly and Company

Enrollment

200 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing LY3541860, an experimental drug, in adults with relapsing multiple sclerosis (MS) — a condition in which the immune system attacks the nervous system, causing episodes of worsening followed by partial recovery. The study aims to evaluate whether this new drug reduces disease activity and relapses. **You may be eligible if...** - You have relapsing MS confirmed by standard diagnostic criteria - You have had at least 1 relapse in the past year, or 2 relapses in the past 2 years, or at least 1 active lesion on a recent brain MRI - Your disability level is moderate or below (EDSS score ≤5.5) **You may NOT be eligible if...** - You have primary progressive MS or non-active secondary progressive MS - You have neuromyelitis optica (a related but different condition) - You have had a relapse treated with steroids within the past 30 days - You have more than 20 active enhancing brain lesions on your MRI scan - You have a current active infection or serious unstable medical illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3541860

Administered IV

DRUGPlacebo

Administered IV

Locations(50)

Healthcare Innovations Institute, LLC

Coral Springs, Florida, United States

Royal Palm Medical Group

Fort Myers, Florida, United States

Eastern Medical Group Research

Fort Myers, Florida, United States

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

Psych Care Consultants Research

St Louis, Missouri, United States

Premier Neurology

Greer, South Carolina, United States

Pauls Stradins Clinical Univeristy Hospital

Riga, Latvia

Centrum Medyczne NeuroProtect

Warsaw, Poland

Centre Hospitalier Universitaire de Clermont Ferrand

Clermont-Ferrand, France

CHRU de Nancy

Nancy, France

CHU Gui De Chauliac

Nîmes, France

Centre Hospitalier Intercommunal - Site de Poissy

Poissy, France

Zentrum für klinische Forschung Dr. med. Irma Schöll

Bad Homburg, Germany

Klinikum Bayreuth GmbH

Bayreuth, Germany

Studienzentrum für Neurologie und Psychiatrie

Böblingen, Germany

Universitatsklinikum Leipzig

Leipzig, Germany

Institut für klinische Neuroimmunologie LMU Muenchen

München, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Nervenfachärztliche Gemeinschaftspraxis Ulm

Ulm, Germany

Galilee Medical Center

Nahariya, Israel

Kaplan Medical Center

Rehovot, Israel

Fondazione Istituto G. Giglio di Cefalù

Cefalù, Italy

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

Klaipeda Hospital, Affiliate of Klaipeda University Hospital

Klaipėda, Lithuania

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

Med-Polonia Sp. z o.o.

Poznan, Poland

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

Poznan, Poland

IBISMED Wielospecjalistyczne Centrum Medyczne

Zabrze, Poland

ProNeuro Centrum Medyczne

Żory, Poland

Queen's Medical Centre

Nottingham, United Kingdom

Prolato Clinical Research Center

Houston, Texas, United States

ANRC Research

El Paso, Texas, United States

USF MS Center

Tampa, Florida, United States

Hope Neurology

Knoxville, Tennessee, United States

Ospedale San Raffaele S.r.l. - PPDS

Milan, Italy

Swedish Multiple Sclerosis Center

Seattle, Washington, United States

Nemocnica Ruzinov

Bratislava, Slovakia

High Quality Research

Miami, Florida, United States

1960 Family Practice, PA

Houston, Texas, United States

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

Milan, Italy

ETG Neuroscience - PPDS

Warsaw, Poland

Neurosphera SP. Z O.O

Warsaw, Poland

View Full Details on ClinicalTrials.gov

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NCT06220669

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