Home › Trials › NCT06220669

Evaluating LY3541860 for adults with relapsing multiple sclerosis

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

Phase 2 Interventional Eli Lilly and Company · NCT06220669

This study is testing a new treatment called LY3541860 to see if it can help adults with relapsing multiple sclerosis feel better and have fewer symptoms.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations54 sites (Coral Springs, Florida and 53 other locations)
Trial IDNCT06220669 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of LY3541860 in adults diagnosed with relapsing forms of multiple sclerosis. Participants will be monitored over a period of approximately 9 months, followed by an additional 6 months for further evaluation. The study includes both an active treatment group receiving LY3541860 and a placebo group to compare outcomes. Eligible participants must have experienced recent disease activity as defined by specific clinical and MRI criteria.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsing-remitting multiple sclerosis who have experienced recent relapses or have active lesions on MRI.

Not a fit: Patients with primary progressive multiple sclerosis or nonactive secondary progressive multiple sclerosis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsing multiple sclerosis, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating relapsing multiple sclerosis with novel therapies, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the McDonald diagnostic criteria (Thompson et al. 2018) with a relapsing course (RMS) activity according to Klineova and Lublin 2018.
* Participants must have 1 of these:

  * at least 1 documented relapse within the previous year
  * at least 2 documented relapses within the previous 2 years, or
  * at least 1 active GdE brain lesion on an MRI scan in the past 180 days prior to screening.
* Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.

Exclusion Criteria:

* Have had a diagnosis of:

  * primary progressive multiple sclerosis (MS) according to the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2018), or
  * nonactive secondary progressive MS ( Klineova and Lublin 2018).
* Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
* Have a history of clinically significant central nervous system (CNS) disease.
* Have had a confirmed relapse with systemic corticosteroid administration \<30 days prior to randomization.
* Have more than 20 active GdE brain lesions on screening MRI scan.
* Have received any of these medications or treatments.
* Have a current or recent acute, active infection.
* Have current serious or unstable illnesses.
* Have any other clinically important abnormality at screening or baseline.

Where this trial is running

Coral Springs, Florida and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisRelapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.