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Monoclonal Antibodies
LY3541860 for Multiple Sclerosis
Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have at least 1 documented relapse within the previous year, or 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.
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.
Must not have
Have a history of clinically significant central nervous system (CNS) disease.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing a new medication called LY3541860 in adults with multiple sclerosis. The goal is to see if the medication is safe and effective in treating the disease. The trial will last for
Who is the study for?
This trial is for adults with relapsing multiple sclerosis, which means their symptoms flare up and then improve. Participants must meet certain health requirements to join.
What is being tested?
The study tests LY3541860 against a placebo over approximately 9 months, followed by a 6-month follow-up, to see if it's safe and effective in treating relapsing multiple sclerosis.
What are the potential side effects?
Specific side effects of LY3541860 are not listed here, but common drug-related side effects in MS treatments may include flu-like symptoms, injection site reactions, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one relapse in the past year or a recent active brain lesion.
Select...
I have been diagnosed with a relapsing form of multiple sclerosis.
Select...
My disability level allows me to walk without aid or rest for 200 meters.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant history of brain or nerve disease.
Select...
I have been diagnosed with primary progressive MS or nonactive secondary progressive MS.
Select...
I do not have any serious or unstable illnesses.
Select...
I currently have or recently had a serious infection.
Select...
I have been diagnosed with neuromyelitis optica spectrum disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Secondary study objectives
Cumulative Number of New and/or Enlarging T2 Lesions
Cumulative Number of Total Number of T1 GdE Lesions
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3541860 Phase 2b Dose Level 4Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group II: LY3541860 Phase 2b Dose Level 3Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group III: LY3541860 Phase 2a Dose Level 2Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group IV: LY3541860 Phase 2a Dose Level 1Experimental Treatment1 Intervention
LY3541860 will be given intravenously (IV)
Group V: Placebo Phase 2bPlacebo Group1 Intervention
Placebo will be given IV.
Group VI: Placebo Phase 2aPlacebo Group1 Intervention
Placebo will be given IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3541860
2021
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,184 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
1,882 Patients Enrolled for Multiple Sclerosis
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,641 Total Patients Enrolled