Status:

ACTIVE_NOT_RECRUITING

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Lead Sponsor:

Eli Lilly and Company

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

Brief 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 wit...

Eligibility Criteria

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.

Key Trial Info

Start Date :

March 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2026

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT06220669

Start Date

March 19 2024

End Date

July 1 2026

Last Update

April 7 2026

Active Locations (20)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (20 locations)

1

Panhandle Research and Medical Clinic

Gulf Breeze, Florida, United States, 32561

2

Conquest Research LLC - Winter Park - ClinEdge - PPDS

Winter Park, Florida, United States, 32789

3

Consultants in Neurology

Northbrook, Illinois, United States, 60062

4

Sharlin Health and Neurology

Ozark, Missouri, United States, 65721-5315

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis | DecenTrialz