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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

Next steps

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.
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (32)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Zentrum fuer klinische Forschung Dr. I. Schoell GmbHBad HomburgGermanyCompleted
Klinikum Bayreuth GmbHBayreuthGermanyCompleted
Studienzentrum Dr. Bischof GmbHBoeblingenGermanyCompleted
Universitaet LeipzigLeipzigGermanyCompleted
Universitaet MuensterMuensterGermanyCompleted
Klinikum der Universitaet Muenchen AöRMunichGermanyCompleted
Rostock University Medical CenterRostockGermanyCompleted
Universitaetsklinikum Tuebingen AöRTuebingenGermanyCompleted
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbHUlmGermanyCompleted
University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceCompleted
CHRU de NancyNancyFranceCompleted
Centre Hospitalier Intercommunal De Poissy Saint GermainPoissyFranceCompleted
Fondazione Istituto G. Giglio Di CafaluCefalu'ItalyCompleted
Ospedale San Raffaele S.r.l.MilanItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo BestaMilanItalyCompleted
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikosKaunasLithuaniaCompleted
Klaipedos universiteto ligonine VšĮKlaipedaLithuaniaCompleted
Pauls Stradins Clinical University HospitalRigaLatviaCompleted
Neurocentrum Bydgoszcz sp. z o.oBydgoszczPolandCompleted
Specjalistyczna Praktyka Lekarska, Prof. Grzegorz OpalaKatowicePolandCompleted
NEURO-MEDIC Sp. z o. o.KatowicePolandCompleted
MA-LEK Clinical Sp. z o.o.KatowicePolandCompleted
Galen ClinicLublinPolandCompleted
Wielospecjalistyc zne Centrum Medyczne IbismedPolskaPolandCompleted
Med Polonia Sp z o.o.PoznanPolandCompleted
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska LekarzyPoznańPolandCompleted
ETG Neuroscience Sp. z o.o.WarsawPolandCompleted
NeuroProtect Sp. z o.o.WarsawPolandCompleted
Neurosphera Sp. z o.o.WarszawaPolandCompleted
Neurokard Sp. z o.o.ZoryPolandCompleted
University Hospital BratislavaBratislavaSlovakiaCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.