Status:
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
- 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
- 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 :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06220669
Start Date
March 19 2024
End Date
August 1 2028
Last Update
December 9 2025
Active Locations (50)
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1
Healthcare Innovations Institute, LLC
Coral Springs, Florida, United States, 33067
2
Royal Palm Medical Group
Fort Myers, Florida, United States, 33901
3
Eastern Medical Group Research
Fort Myers, Florida, United States, 33908
4
Panhandle Research and Medical Clinic
Gulf Breeze, Florida, United States, 32561