2023-503289-22-00CompletedPhase 2
“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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Jan 2026
Brief summary (registry, in English)
To evaluate the efficacy of LY3541860 versus placebo on the number of new T1 GdE MRI brain lesions in participants with RMS
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 18 Jan 2024
- Start date
- 5 Jul 2024
- Lead sponsor
- Eli Lilly & Co.
- Diseases
- Multiple sclerosis
- EU CT number
- 2023-503289-22-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 57
- 32 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zentrum fuer klinische Forschung Dr. I. Schoell GmbH | Bad Homburg | Germany | Completed |
| Klinikum Bayreuth GmbH | Bayreuth | Germany | Completed |
| Studienzentrum Dr. Bischof GmbH | Boeblingen | Germany | Completed |
| Universitaet Leipzig | Leipzig | Germany | Completed |
| Universitaet Muenster | Muenster | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Completed |
| Rostock University Medical Center | Rostock | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Completed |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH | Ulm | Germany | Completed |
| University Hospital Of Clermont-Ferrand | Clermont Ferrand Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Completed |
| CHRU de Nancy | Nancy | France | Completed |
| Centre Hospitalier Intercommunal De Poissy Saint Germain | Poissy | France | Completed |
| Fondazione Istituto G. Giglio Di Cafalu | Cefalu' | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta | Milan | Italy | Completed |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos | Kaunas | Lithuania | Completed |
| Klaipedos universiteto ligonine VšĮ | Klaipeda | Lithuania | Completed |
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Completed |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | Poland | Completed |
| Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala | Katowice | Poland | Completed |
| NEURO-MEDIC Sp. z o. o. | Katowice | Poland | Completed |
| MA-LEK Clinical Sp. z o.o. | Katowice | Poland | Completed |
| Galen Clinic | Lublin | Poland | Completed |
| Wielospecjalistyc zne Centrum Medyczne Ibismed | Polska | Poland | Completed |
| Med Polonia Sp z o.o. | Poznan | Poland | Completed |
| NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy | Poznań | Poland | Completed |
| ETG Neuroscience Sp. z o.o. | Warsaw | Poland | Completed |
| NeuroProtect Sp. z o.o. | Warsaw | Poland | Completed |
| Neurosphera Sp. z o.o. | Warszawa | Poland | Completed |
| Neurokard Sp. z o.o. | Zory | Poland | Completed |
| University Hospital Bratislava | Bratislava | Slovakia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.