LY3541860 for Multiple Sclerosis

Recruiting at 52 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

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: 0

Duration: 9 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The study will last about 9 months with additional 6 months follow-up.

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.

What data supports the effectiveness of the drug LY3541860 for multiple sclerosis?

Research on a similar drug, fingolimod (FTY720), shows it can reduce relapses in multiple sclerosis patients by over 50% compared to a placebo, suggesting potential effectiveness for LY3541860. ^{1 2 3 4 5}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

References

1. Netherlands 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Oral fingolimod (FTY720) for relapsing multiple sclerosis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[FTY720 (Fingolimod) as a new therapeutic option for multiple sclerosis]. [2018]

5. United States 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. [2016]