Not recruiting

Study of LY3541860 and Meglumine Gadoterate for Adults with Relapsing Multiple Sclerosis

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Relapsing Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study will evaluate a new treatment called LY3541860, which is being compared to a placebo. The aim is to see if LY3541860 can slow down the formation of new brain lesions, which are areas of damage in the brain, in people with this type of multiple sclerosis.

Participants in the study will receive either the new treatment or a placebo. The treatment involves an injection, and the study will monitor the participants over a period to observe any changes in the number of new brain lesions. These lesions are detected using MRI scans, a type of imaging that helps doctors see inside the body without surgery. The study will help determine if LY3541860 is effective in reducing the occurrence of these lesions.

In addition to LY3541860, the study will also use Gadoteric Acid, a contrast agent used in MRI scans to improve the clarity of the images. This agent is injected into the body to help highlight certain areas during the scan. The study will provide valuable information on the safety and effectiveness of LY3541860 in treating relapsing multiple sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be randomly assigned to receive either the investigational medication LY3541860 or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.
Step 2
Medication administration
The medication, LY3541860, is administered as a solution for injection. The exact dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the trial.
Step 3
Monitoring and assessments
Throughout the study, participants will undergo regular magnetic resonance imaging (MRI) scans to monitor the occurrence of new T1 gadolinium-enhancing lesions in the brain. These scans are crucial for assessing the effectiveness of the treatment.
Step 4
Safety evaluations
Participants will be regularly evaluated for any side effects or adverse reactions to the medication. This includes routine health check-ups and assessments by the study team.
Step 5
Completion of the study
The study is estimated to conclude by March 20, 2026. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

7 criteria

Participants must have a type of multiple sclerosis called relapsing forms of multiple sclerosis, which includes relapsing-remitting multiple sclerosis. This is based on specific guidelines from 2017.
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Participants must have experienced at least one of the following:
- At least one documented relapse (a return of symptoms) within the past year.
- At least two documented relapses within the past two years.
- At least one active GdE brain lesion (a specific type of spot seen on an MRI scan) in the past 180 days before the study starts.
- Participants must have a score of 5.5 or less on the Expanded Disability Status Scale (EDSS), which is a way to measure disability in people with multiple sclerosis, at the time of screening and when they are randomly assigned to a group in the study.
- Both men and women can participate in the study.
- The study does not include vulnerable populations, which means people who might need special protection or care.

Who cannot join the trial?

4 criteria

Patients who do not have Relapsing Multiple Sclerosis cannot participate. This is a type of multiple sclerosis where symptoms come and go.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not listed here but are important for safety and accuracy.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier Intercommunal De Poissy Saint Germain
St Germain En Laye, France
Verified
Centre Hospitalier Universitaire De Montpellier
Montpellier, France

Trial locations

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Investigated drugs

LY3541860 is a medication being studied for its potential to slow down the formation of new brain lesions in people with relapsing multiple sclerosis. The trial aims to assess how effective this medication is in reducing the number of new lesions that appear on MRI scans of the brain.

What is already known about the treatment

LY3541860 – This medication is administered orally and is currently being studied in clinical trials for its potential to treat relapsing multiple sclerosis. It is in the experimental phase, with ongoing research to determine its safety and effectiveness. The main therapeutic indication is to reduce the occurrence of new brain lesions in patients with this condition. At the molecular level, LY3541860 is believed to work by modulating the immune system to prevent inflammation and damage to nerve cells. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or increasing neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease involves an immune-mediated process where the body's immune system attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. Over time, this can result in permanent damage or deterioration of the nerves. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and vision problems. The progression of the disease can be unpredictable, with some individuals experiencing frequent relapses and others having long periods of stability.