LY3541860 for Multiple Sclerosis

Recruiting at 63 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Primary progressive MS, CNS disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of a new treatment, LY3541860, for people with multiple sclerosis (MS) that cycles between worsening and improvement. Participants will receive either the treatment or a placebo through an IV. The study will last about nine months, followed by an additional six months of follow-up. Ideal candidates have been diagnosed with relapsing forms of MS, have experienced recent relapses, or have specific brain scan results. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in MS treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had a confirmed relapse with systemic corticosteroid use within 30 days before starting the trial.

Is there any evidence suggesting that LY3541860 is likely to be safe for humans?

Research shows that LY3541860 is being tested for safety in people with relapsing multiple sclerosis. Since this treatment is in Phase 2, researchers are still learning about its tolerability. Earlier testing stages focus on ensuring treatments are safe, and reaching Phase 2 means LY3541860 has passed those initial safety checks.

While specific information on side effects for LY3541860 is not yet available, reaching this phase suggests that any observed side effects have been manageable. Researchers will closely monitor participants for any unexpected reactions to ensure their safety throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Researchers are excited about LY3541860 for multiple sclerosis because it offers a potentially new way to tackle this condition. Unlike standard treatments like interferons or monoclonal antibodies, which mainly focus on modulating the immune system to reduce inflammation, LY3541860 is administered intravenously and might work differently by targeting specific pathways involved in the disease. This could mean a new mechanism of action that might lead to better outcomes for patients who don't respond well to current therapies. The excitement also stems from the possibility that LY3541860 might provide more effective symptom control or fewer side effects compared to existing options.

What evidence suggests that LY3541860 might be an effective treatment for multiple sclerosis?

Research has shown that LY3541860 might help treat relapsing multiple sclerosis, a form of the disease that comes and goes. In studies with patients who have this type of multiple sclerosis, treatments like LY3541860 reduced new damaged areas seen on MRI scans. These studies also reported fewer flare-ups of symptoms each year. This suggests LY3541860 could help control the disease and possibly slow the worsening of symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have a significant history of brain or nerve disease.

I do not have any serious or unstable illnesses.

I have received specific medications or treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3541860 or placebo intravenously to evaluate safety and efficacy

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• LY3541860

Trial Overview 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.

How Is the Trial Designed?

Group I: LY3541860 Phase 2b Dose Level 4 Experimental Treatment 1 Intervention

LY3541860 will be given IV.

Group II: LY3541860 Phase 2b Dose Level 3 Experimental Treatment 1 Intervention

LY3541860 will be given IV.

Group III: LY3541860 Phase 2a Dose Level 2 Experimental Treatment 1 Intervention

LY3541860 will be given IV.

Group IV: LY3541860 Phase 2a Dose Level 1 Experimental Treatment 1 Intervention

LY3541860 will be given intravenously (IV)

Group V: Placebo Phase 2b Placebo Group 1 Intervention

Placebo will be given IV.

Group VI: Placebo Phase 2a Placebo Group 1 Intervention

Placebo will be given IV.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

FTY720 (fingolimod) is an oral medication for multiple sclerosis that has shown promising results in a phase II trial, reducing relapse rates by over 50% compared to placebo.

The safety profile of FTY720 appears acceptable, and its innovative mechanism targets key elements in the disease's progression, with further confirmation expected from ongoing phase III studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[FTY720 (Fingolimod) as a new therapeutic option for multiple sclerosis]. Klatt, J., Hartung, HP., Hohlfeld, R.[2018]

In a comparison of 512 patients treated with peginterferon beta-1a and 731 patients treated with teriflunomide, peginterferon beta-1a was associated with a significantly lower rate of 24-week confirmed disability worsening (CDW) at 108 weeks (8.4% vs 12.6%).

Patients newly diagnosed with relapsing multiple sclerosis who received peginterferon beta-1a had numerically lower annualized relapse rates (ARR) compared to those treated with teriflunomide, with this trend continuing for up to 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-adjusted comparisons demonstrate better clinical outcomes in patients with relapsing multiple sclerosis treated with peginterferon beta-1a than with teriflunomide. Newsome, SD., Mokliatchouk, O., Castrillo-Viguera, C., et al.[2021]

In a study of 171 Japanese patients with relapsing multiple sclerosis, fingolimod showed significant efficacy, with 70% of patients on the 0.5 mg dose and 86% on the 1.25 mg dose free from gadolinium-enhanced lesions at six months, compared to only 40% in the placebo group.

While fingolimod was effective, some patients experienced adverse effects such as transient bradycardia and elevated liver enzymes, highlighting the need for monitoring during treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Saida, T., Kikuchi, S., Itoyama, Y., et al.[2022]

In a study of 281 patients with relapsing multiple sclerosis, fingolimod significantly reduced the number of MRI-detected lesions and the annual relapse rate compared to placebo, indicating its efficacy as a treatment option.

While fingolimod showed promising results, it was associated with some adverse effects, including elevated liver enzymes and a case of posterior reversible encephalopathy syndrome, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral fingolimod (FTY720) for relapsing multiple sclerosis. Kappos, L., Antel, J., Comi, G., et al.[2022]

FTY720 significantly reduced inflammatory activity in a rat model of multiple sclerosis, as evidenced by the absence of neurological impairment and inflammatory signs in treated animals compared to untreated ones.

The study utilized advanced imaging techniques to track macrophages, demonstrating that FTY720 effectively modulates the immune response and protects the blood-brain barrier during both acute and relapse phases of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictability of FTY720 efficacy in experimental autoimmune encephalomyelitis by in vivo macrophage tracking: clinical implications for ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging. Rausch, M., Hiestand, P., Foster, CA., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06220669

A Study of LY3541860 in Adult Participants With Relapsing ... The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12052076/

Update on novel multiple sclerosis treatments - PubMed Central This review is an update on current clinical trials of unapproved disease modifying medical treatments that have either recently completed or are underway

3. trials.lilly.com trials.lilly.com/en-US/trial/453415

A Study of LY3541860 in Adult Participants With ... - Lilly Trials The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better ...

4. withpower.com withpower.com/trial/phase-2-multiple-sclerosis-2024-be220

LY3541860 for Multiple Sclerosis In a study of 281 patients with relapsing multiple sclerosis, fingolimod significantly reduced the number of MRI-detected lesions and the annual relapse rate ...

5. nationalmssociety.org nationalmssociety.org/how-you-can-help/get-involved/participate-in-research-studies/participate-in-clinical-trials/ct-ly3541860-for-relapsing-ms

Clinical Trial: LY3541860 in Relapsing MS The outcomes being measured in this study are disease activity as measured by magnetic resonance imaging (MRI) scans and how the drug is absorbed in blood ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-of-ly3541860-and-meglumine-gadoterate-for-adults-with-relapsing-multiple-sclerosis/

Study of LY3541860 and Meglumine Gadoterate for Adults ... The study will provide valuable information on the safety and effectiveness of LY3541860 in treating relapsing multiple sclerosis. 1joining ...