Active not recruitingPHASE2INTERVENTIONAL

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

This research study is looking at a new medication called LY3541860 for adults who have relapsing multiple sclerosis (MS). This is a type of MS where you have periods of symptoms getting worse (relapses) followed by recovery. The main goals are to check how safe the drug is and how well it works to control MS. Participants will either receive the new drug or a placebo (a dummy drug with no active ingredients). The study involves regular check-ups over approximately 9 months, followed by an additional 6 months of monitoring. We hope to learn if LY3541860 could be a helpful treatment option for people living with relapsing MS.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

Start

19 Mar 2024

Estimated completion

01 Jul 2026

Multiple Sclerosis

What is this study about?

This study is designed to explore a new potential treatment, LY3541860, for people living with relapsing multiple sclerosis (MS). Relapsing MS is a common type where symptoms come and go, often called flare-ups or relapses, which can cause new or worsening problems like weakness, numbness, or vision issues. Finding effective ways to manage these relapses and slow down the disease's progression is really important for people with MS.

In this study, researchers want to see two main things: first, is LY3541860 safe for people with relapsing MS? And second, does it help to reduce the number or severity of MS relapses? Participants will be carefully monitored throughout the study to track any changes in their MS symptoms and overall health. Some people will receive the new drug, while others will receive a placebo, which looks like the drug but contains no active medicine. This comparison helps researchers understand the true effects of the new treatment.

The findings from this study could be a crucial step towards developing new treatments for relapsing MS. Every new medicine goes through several stages of testing, and this study, known as Phase 2, helps us understand how a drug works in a larger group of people, after earlier tests have shown it to be potentially effective and safe in a smaller number of people. The information gathered here will guide future research and potentially lead to better care for individuals with MS.

Key takeaways

A new drug, LY3541860, is being tested for relapsing multiple sclerosis.
The study aims to check the safety and effectiveness of the drug.
Participants will receive either the new drug or a placebo.
The total study duration is about 15 months, including follow-up.
It's a Phase 2 trial, meaning it's an earlier stage clinical study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 55 years old and have a specific type of multiple sclerosis called relapsing-remitting MS. This means you experience periods where your MS symptoms get worse (relapses) followed by times of recovery. You would also need to have had at least one relapse in the last year, or two relapses in the past two years, or show signs of MS activity on a recent brain scan (MRI).

There are also some reasons why you might not be able to join. For example, if you have other types of MS like primary progressive MS or non-active secondary progressive MS, or if you have a different condition called neuromyelitis optica spectrum disorder. We also can't include people with certain other serious medical conditions, recent infections, or those who have had a severe MS relapse treated with steroids very recently. Your doctors will review your full medical history to make sure the study is a safe and appropriate option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Do you have relapsing-remitting MS, not other types?
Have you had recent MS relapses or active MS shown on an MRI scan?
Is your MS-related disability level not too severe?
Do you have any other serious medical conditions or recent infections?
Have you recently received certain MS medications or treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be involved for approximately 9 months of treatment and assessments, followed by another 6 months where we will continue to monitor your health. During the 9-month treatment period, you will receive either the investigational drug LY3541860 or a placebo. This will involve regular visits to the clinic for various assessments. These assessments will likely include physical examinations, blood tests, neurological check-ups, and possibly MRI scans to monitor your brain for MS activity. We will also ask you questions about your symptoms and how you are feeling.

The follow-up period of 6 months will involve fewer visits, mainly to keep an eye on your long-term health and any ongoing effects. The research team will explain all the procedures in detail, including how often you'll need to visit, what each visit involves, and any medication you'll need to take. The total time commitment for the entire study, including follow-up, will be around 15 months.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available yet, which might help your MS. It also contributes valuable information that could lead to better treatments for others with MS in the future. However, there are potential risks, as with any new medication. You might experience side effects from the study drug, or the placebo might not help your MS. The research team will monitor you closely for any issues, but there's no guarantee the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Panhandle Research and Medical Clinic
Verified postcode
Gulf Breeze, United States
Conquest Research LLC - Winter Park - ClinEdge - PPDS
Verified postcode
Winter Park, United States
Consultants in Neurology
Verified postcode
Northbrook, United States
Sharlin Health and Neurology
Verified postcode
Ozark, United States
Premier Neurology
Verified postcode
Greer, United States
Hope Neurology
Verified postcode
Knoxville, United States
Centre Hospitalier Intercommunal - Site de Poissy
Verified postcode
Poissy, France
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Verified postcode
Milan, Italy
Pauls Stradins Clinical Univeristy Hospital
Verified postcode
Riga, Latvia
Neurocentrum Bydgoszcz sp. z o.o.
Verified postcode
Bydgoszcz, Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Verified postcode
Katowice, Poland
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
Verified postcode
Katowice, Poland

Common questions

What is multiple sclerosis (MS) and why is this study important?

MS is a condition that affects your brain and spinal cord, causing symptoms like numbness, fatigue, and problems with movement. This study is important because it's testing a new drug that could potentially help manage a common type of MS called relapsing MS.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It's used in studies to compare the new drug's effects against doing nothing, helping researchers understand if the new drug truly works.

How long will I be involved in the study?

The study involves about 9 months of receiving the treatment and having regular check-ups, followed by an additional 6 months of monitoring your health. So, the total time will be around 15 months.

Will I know if I'm getting the active drug or the placebo?

During the main part of the study, you won't know if you're receiving the active drug or the placebo. This helps ensure the results are fair and unbiased. Your study team will be able to tell you after the study is complete, if appropriate.

What if I change my mind about participating?

You are free to leave the study at any point, for any reason, without having to explain why. Your decision will not affect your ongoing medical care.