RECRUITING

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Description

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.

Conditions

Multiple Sclerosis
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Related Conditions:

Multiple Sclerosis

Study Overview

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Study Details

Study overview

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.

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

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Coral Springs

Healthcare Innovations Institute, LLC, Coral Springs, Florida, United States, 33067

Pensacola

Panhandle Research and Medical Clinic, Pensacola, Florida, United States, 32503-3025

Tampa

USF MS Center, Tampa, Florida, United States, 33612

Winter Park

Conquest Research LLC - Winter Park - ClinEdge - PPDS, Winter Park, Florida, United States, 32789

Northbrook

Consultants In Neurology, Northbrook, Illinois, United States, 60062

Ozark

Sharlin Health and Neurology, Ozark, Missouri, United States, 65721-5315

Greer

Premier Neurology, Greer, South Carolina, United States, 29605

Knoxville

Hope Neurology, Knoxville, Tennessee, United States, 37922

El Paso

ANRC Research, El Paso, Texas, United States, 79912-1743

Houston

Prolato Clinical Research Center, Houston, Texas, United States, 77054-2852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2028-08