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Active, Not Recruiting

NCT Number: NCT06220669

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Intercommunal - Site de Poissy, Poissy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3541860

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  1. Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

    Time frame: 12 Weeks

    Cumulative number will be measured by magnetic resonance imaging (MRI) scans.

Secondary outcomes

  1. Cumulative Number of Total Number of T1 GdE Lesions

    Time frame: 12 Weeks

    Cumulative number will be measured by MRI scans.

  2. Cumulative Number of New and/or Enlarging T2 Lesions

    Time frame: 12 Weeks

    Cumulative number will be measured by MRI scans.

  3. Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860

    Time frame: Baseline Through Week 12

    Plasma trough concentrations of LY3541860 was measured.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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