RECRUITING

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Conditions

Multiple Sclerosis Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-19

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06220669

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.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559

ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

Healthcare Innovations Institute, LLC

Coral Springs, Florida, 33067

United States

Panhandle Research and Medical Clinic

Pensacola, Florida, 32503-3025

United States

USF MS Center

Tampa, Florida, 33612

United States

Conquest Research LLC - Winter Park - ClinEdge - PPDS

Winter Park, Florida, 32789

United States

Consultants In Neurology

Northbrook, Illinois, 60062

United States

Sharlin Health and Neurology

Ozark, Missouri, 65721-5315

United States

Premier Neurology

Greer, South Carolina, 29605

United States

Hope Neurology

Knoxville, Tennessee, 37922

United States

ANRC Research

El Paso, Texas, 79912-1743

United States

Prolato Clinical Research Center

Houston, Texas, 77054-2852

United States

Swedish Multiple Sclerosis Center

Seattle, Washington, 98122

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-19

Study Completion Date2028-08

Study Record Updates

Study Start Date2024-03-19

Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.

Additional Relevant MeSH Terms

Multiple Sclerosis