Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Adaptive Phase 2a/2b, Randomized, Double-Blind, Parallel-Group Study to Investigate the Safety and Efficacy of LY3541860 Compared to Placebo in Slowing the Occurrence of New T1 Gadolinium-Enhancing Lesions in Adult Participants with Relapsing Multiple Sclerosis

This trial is for adults with relapsing multiple sclerosis (RMS) and is testing a new medicine called LY3541860. The main goal is to find out if this medicine can help lower the number of new brain lesions, which are often seen on special brain scans called MRIs. These lesions are a sign of MS activity. Some participants will receive the new medicine, while others will get a placebo (a dummy treatment) to see if the new medicine is effective. It's a 'double-blind' study, meaning neither the patient nor the doctor knows who is getting which treatment, to ensure fair results. The study also aims to check how safe the new medicine is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

13 May 2024

Relapsing Multiple Sclerosis

What is this study about?

This study is designed to explore a new potential treatment, called LY3541860, for people living with relapsing multiple sclerosis (RMS). RMS is a condition where the body's immune system mistakenly attacks the protective covering of nerves. This can lead to various symptoms that come and go, or get better and worse. One way doctors monitor MS activity is by looking for new spots, called lesions, on the brain or spinal cord using special scans called MRI.

The main purpose of this research is to see if LY3541860 can help reduce the appearance of these new lesions on MRI scans. Fewer new lesions often suggest that the disease activity might be slowing down. Participants in this study will either receive the new medicine or a placebo, which looks just like the real medicine but contains no active drug. Receiving a placebo helps researchers properly compare the effects of the new medicine.

This is a 'Phase 2' study. This means the researchers are trying to understand more about how the new medicine works, if it's safe to use, and what dose might be most effective. It's an important step in developing new treatments, but it's not yet known if this medicine will become widely available. The study is carefully designed to gather accurate information.

Key takeaways

This study is for adults with relapsing multiple sclerosis (RMS).
It's testing a new medicine (LY3541860) against a dummy treatment (placebo).
The main goal is to see if the medicine reduces new brain lesions on MRI scans.
Participation involves regular clinic visits, blood tests, and MRI scans.
You will be closely monitored for your safety and health.

Who may be eligible?

This study is looking for adult volunteers of all genders who have been diagnosed with relapsing multiple sclerosis (RMS). To be considered, you must be at least 18 years old. There is no upper age limit for taking part.

There will be other, more specific medical criteria that your doctor and the study team will need to check to make sure the study is a good fit for you and that you can participate safely. For example, they will need to look at your full medical history and current health status.

If you are interested, your first step would be to talk to your doctor or the study team. They can go through all the detailed requirements with you and help determine if this particular study might be an 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 18 years old or older?
Have you been diagnosed with relapsing multiple sclerosis (RMS)?
Are you able to attend regular clinic appointments and have MRI scans?
Are you willing to potentially receive a placebo?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, LY3541860, or a placebo (a dummy treatment). You would receive these treatments over a period of time, and neither you nor your study doctor would know which one you are getting. This helps ensure the results are fair and unbiased.

Your participation would involve regular visits to a clinic for check-ups and assessments. These visits would include physical examinations, blood tests, and importantly, several MRI scans of your brain. The MRI scans are crucial for checking for any new lesions. You would also be asked questions about how you are feeling and any symptoms you might experience.

Throughout the study, the research team would closely monitor your health and safety. The total duration of the study would be explained to you in detail before you decide to join. There would also be follow-up appointments after you finish taking the study medication to make sure you are doing well.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help future patients with MS, and you would receive close medical monitoring throughout the study. However, there are also potential risks; the new medicine might cause side effects, some of which could be serious, or it might not work for you. The placebo in the study has no active medication, so it wouldn't directly help your MS, though some people feel better due to the extra care they receive. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Italy
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Unverified
Lithuania
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Unverified
Germany
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Unverified
Poland
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Unverified
France
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Unverified
Latvia
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Unverified
Slovakia

Common questions

What is relapsing multiple sclerosis (RMS)?

RMS is a type of multiple sclerosis where you have periods of new or worsening symptoms (relapses) followed by periods of recovery.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It's used to compare against the new medicine.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps make the study fair.

What are 'T1 Gadolinium-Enhancing Lesions'?

These are active spots on your brain that show up on a special type of MRI scan. They suggest current inflammation or damage related to MS.

Will I have to pay to be in this study?

No, you should not have to pay to participate in a clinical trial. All study-related treatments and assessments are typically provided Free of Charge.