A Study of LY3541860 in Adult Participants 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06220669

Enrollment

Registered

2024-01-24

Start date

2024-03-19

Completion date

2026-07-01

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.

Brief summary

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.

Interventions

DRUGLY3541860

Administered IV

DRUGPlacebo

Administered IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions	12 Weeks	Cumulative number will be measured by magnetic resonance imaging (MRI) scans.

Secondary

Measure	Time frame	Description
Cumulative Number of Total Number of T1 GdE Lesions	12 Weeks	Cumulative number will be measured by MRI scans.
Cumulative Number of New and/or Enlarging T2 Lesions	12 Weeks	Cumulative number will be measured by MRI scans.
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860	Baseline Through Week 12	Plasma trough concentrations of LY3541860 was measured.

Countries

France, Italy, Latvia, Poland, Slovakia, United Kingdom, United States

Contacts

STUDY_DIRECTORCall 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)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026