“A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis”
Key facts
- Where
- Bydgoszcz, Katowice, Lublin, Polska, Poznan, Poznań, Warsaw, Warszawa és Zory, LengyelországSee the 12 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- Neurocentrum Bydgoszcz sp. z o.oBydgoszcz, LengyelországNo longer taking part
- MA-LEK Clinical Sp. z o.o.Katowice, LengyelországNo longer taking part
- NEURO-MEDIC Sp. z o. o.Katowice, LengyelországNo longer taking part
- Specjalistyczna Praktyka Lekarska, Prof. Grzegorz OpalaKatowice, LengyelországNo longer taking part
- Galen ClinicLublin, LengyelországNo longer taking part
- Wielospecjalistyc zne Centrum Medyczne IbismedPolska, LengyelországNo longer taking part
- Med Polonia Sp z o.o.Poznan, LengyelországNo longer taking part
- NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska LekarzyPoznań, LengyelországNo longer taking part
- ETG Neuroscience Sp. z o.o.Warsaw, LengyelországNo longer taking part
- NeuroProtect Sp. z o.o.Warsaw, LengyelországNo longer taking part
- Neurosphera Sp. z o.o.Warszawa, LengyelországNo longer taking part
- Neurokard Sp. z o.o.Zory, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly & Co.
- Trial code
- EU 2023-503289-22-00
- Record updated
- 2026. január 9.
- Original description
To evaluate the efficacy of LY3541860 versus placebo on the number of new T1 GdE MRI brain lesions in participants with RMSRead full original descriptionShow less
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
To evaluate the efficacy of LY3541860 versus placebo on the number of new T1 GdE MRI brain lesions in participants with RMS
Inclusion: 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: 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.