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Monoclonal Antibodies

LY3541860 Phase 2b Dose Level 3 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I have had at least one relapse in the past year or a recent active brain lesion.

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I have been diagnosed with a relapsing form of multiple sclerosis.

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My disability level allows me to walk without aid or rest for 200 meters.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,399 Total Patients Enrolled

7 Trials studying Multiple Sclerosis

1,882 Patients Enrolled for Multiple Sclerosis

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,545 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 30 eligible to participate in this medical study?

"Applicants aged above 18 years and below 55 years are eligible for participation in this research."

Answered by AI

Are there any opportunities for eligible individuals to participate in this ongoing research study?

"As per the information on clinicaltrials.gov, this particular study is not presently accepting new participants. The trial was initially listed for recruitment on January 25th, 2024 and last modified on January 15th, 2024. However, it's worth noting that there are currently 532 other trials actively seeking patients at this time."

Answered by AI

Can I be considered a suitable candidate to partake in this clinical study?

"To be eligible for participation in this clinical trial, patients must have a diagnosis of multiple sclerosis and fall within the age range of 18 to 55 years. The study aims to enroll approximately 200 individuals with this condition."

Answered by AI

Are there multiple locations within the state where this clinical trial is being conducted?

"Patients can actively enroll in this clinical trial at various locations, including the USF MS Center located in Tampa, Consultants In Neurology situated in Northbrook, and Hope Neurology based in Knoxville. Furthermore, there are five additional sites where patients can participate."

Answered by AI

What level of risk does LY3541860 Phase 2b Dose Level 4 pose to individuals?

"The safety rating for LY3541860 Phase 2b Dose Level 4 is estimated to be a 2, as indicated by our team at Power. Since this trial is in Phase 2, there exists preliminary data supporting its safety but not yet demonstrating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

2024. "A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06220669.

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