200 Participants Needed

LY3541860 for Multiple Sclerosis

Recruiting at 52 trial locations
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Overseen ByThere 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
Prior Safety DataThis treatment has passed at least one previous human trial

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 LY3541860.12345

Research Team

C1

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.
See 6 more

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 OverviewThe 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
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3541860 Phase 2b Dose Level 4Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group II: LY3541860 Phase 2b Dose Level 3Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group III: LY3541860 Phase 2a Dose Level 2Experimental Treatment1 Intervention
LY3541860 will be given IV.
Group IV: LY3541860 Phase 2a Dose Level 1Experimental Treatment1 Intervention
LY3541860 will be given intravenously (IV)
Group V: Placebo Phase 2bPlacebo Group1 Intervention
Placebo will be given IV.
Group VI: Placebo Phase 2aPlacebo Group1 Intervention
Placebo will be given IV.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

References

Matching-adjusted comparisons demonstrate better clinical outcomes in patients with relapsing multiple sclerosis treated with peginterferon beta-1a than with teriflunomide. [2021]
Oral fingolimod (FTY720) for relapsing multiple sclerosis. [2022]
A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. [2022]
[FTY720 (Fingolimod) as a new therapeutic option for multiple sclerosis]. [2018]
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]