A Study of LY3541860 in Adult Participants With Relapsing Multiple Scl
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
What it found
The trial was stopped early because the treatment was not working.
Reason given: The interim analysis data failed to demonstrate the intended treatment effect.
What was tested
Treatment tested
- LY3541860
Placebo
- Placebo
- 0.9% sodium chloride
What it measured
Main measures
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
12 Weeks
MRI lesionsCumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions Cumulative number will be measured by magnetic resonance imaging (MRI) scans
MRI lesions
Other measures (3)
Cumulative Number of Total Number of T1 GdE Lesions
12 Weeks
MRI lesionsCumulative Number of New and/or Enlarging T2 Lesions
12 Weeks
MRI lesionsPharmacokinetics (PK): Plasma Trough Concentrations of LY3541860
Baseline Through Week 12
How the body handles the medicine
Who could take part
Relapsing and progressive · 18 to 55
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
- Has posted results changed from false to true
Started
Mar 2024
Main results due
Oct 2025
Finished
Jul 2026
Results posted
Oct 2026