Multiple Sclerosis Clinical Trial

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT06220669

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 41 Locations for this study

See Locations Near You

Healthcare Innovations Institute, LLC
Coral Springs Florida, 33067, United States More Info
Contact
954-530-5844
Sonia Kalirao
Principal Investigator
USF MS Center
Tampa Florida, 33612, United States More Info
Contact
813-974-9423
Natalie Moreo
Principal Investigator
Conquest Research LLC - Winter Park - ClinEdge - PPDS
Winter Park Florida, 32789, United States More Info
Contact
407-916-0041
Rekha Gandhi
Principal Investigator
Consultants In Neurology
Northbrook Illinois, 60062, United States More Info
Contact
847-509-0270
Daniel Wynn
Principal Investigator
Sharlin Health and Neurology
Ozark Missouri, 65721, United States More Info
Contact
417-485-4330
Kenneth Sharlin
Principal Investigator
Premier Neurology
Greer South Carolina, 29605, United States More Info
Contact
864-655-4005
Mary Hughes
Principal Investigator
Hope Neurology
Knoxville Tennessee, 37922, United States More Info
Contact
865-218-6222
Sibyl Wray
Principal Investigator
Swedish Multiple Sclerosis Center
Seattle Washington, 98122, United States More Info
Contact
206-320-2200
Kathryn Fong
Principal Investigator
CHU Gui De Chauliac
Nîmes Gard, 30029, France More Info
Contact
33467337413
Pierre Labauge
Principal Investigator
CHRU de Nancy
Nancy Meurthe-et-Moselle, 54000, France More Info
Contact
+33383851688
Guillaume Mathey
Principal Investigator
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand Puy-de-Dôme, 63000, France More Info
Contact
33473752200
Pierre Clavelou
Principal Investigator
Centre Hospitalier Intercommunal - Site de Poissy
Poissy Yvelines, 78303, France More Info
Contact
33139274181
Olivier Heinzlef
Principal Investigator
Studienzentrum für Neurologie und Psychiatrie
Böblingen Baden-Württemberg, 71034, Germany More Info
Felix Bischof
Principal Investigator
Universitätsklinikum Tübingen
Tübingen Baden-Württemberg, 72076, Germany More Info
Contact
4970712987529
Markus Kowarik
Principal Investigator
Nervenfachärztliche Gemeinschaftspraxis Ulm
Ulm Baden-Württemberg, 89073, Germany More Info
Contact
497311775220
Daniela Rau
Principal Investigator
Klinikum Bayreuth GmbH
Bayreuth Bayern, 95445, Germany More Info
Contact
499214004602
Patrick Oschmann
Principal Investigator
Klinikum Großhadern, LMU
München Bayern, 81377, Germany More Info
Contact
4989440074435
Tania Kümpfel
Principal Investigator
Zentrum für klinische Forschung Dr. med. Irma Schöll
Bad Homburg Hessen, 61348, Germany More Info
Contact
4906172679573
Elvira Steidl
Principal Investigator
Universitätsklinik Rostock
Rostock Mecklenburg-Vorpommern, 18147, Germany More Info
Contact
493814949517
Uwe Zettl
Principal Investigator
Universitätsklinikum Münster
Münster Nordrhein-Westfalen, 48149, Germany More Info
Contact
492518348140
Luisa Klotz
Principal Investigator
Universitatsklinikum Leipzig
Leipzig Sachsen, 4103, Germany More Info
Contact
493419724307
Florian Then Bergh
Principal Investigator
Kaplan Medical Center
Rehovot HaMerkaz, 76100, Israel More Info
Contact
97289441228
Anda Eilam
Principal Investigator
Galilee Medical Center
Nahariya HaZafon, 22100, Israel More Info
Contact
97249107022
Samih Badarny
Principal Investigator
Barzilai Medical Center
Ashkelon , 78278, Israel More Info
Contact
97286745117
Ron Milo
Principal Investigator
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 00152, Italy More Info
Contact
390658704272
Claudio Gasperini
Principal Investigator
Ospedale San Raffaele S.r.l. - PPDS
Milano Lombardia, 20132, Italy More Info
Contact
390226433054
Massimo Filippi
Principal Investigator
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Milano Lombardia, 20133, Italy More Info
Contact
390223942282
Sebastiano Crisafulli
Principal Investigator
Fondazione Istituto G. Giglio di Cefalù
Cefalù Sicilia, 90015, Italy More Info
Contact
398888888888
Luigi Grimaldi
Principal Investigator
Pauls Stradins Clinical Univeristy Hospital
Riga , LV-10, Latvia More Info
Contact
37129333334
Alina Flintere-Flinte
Principal Investigator
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas Kauno Apskritis, 50009, Lithuania More Info
Contact
37037326962
Dalia Mickeviciene
Principal Investigator
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda Klaipedos Apskritis, LT-92, Lithuania More Info
Contact
37061863515
Povilas Beliaziunas
Principal Investigator
Neurocentrum Bydgoszcz sp. z o.o.
Bydgoszcz Kujawsko-Pomorskie, 85-79, Poland More Info
Contact
48601633810
Robert Bonek
Principal Investigator
Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz
Lublin Lubelskie, 20-95, Poland More Info
Contact
48817244720
Urszula Chyrchel-Paszkiewicz
Principal Investigator
Centrum Medyczne NeuroProtect
Warszawa Mazowieckie, 01-81, Poland More Info
Contact
48501762789
Maciej Czarnecki
Principal Investigator
Centrum Medyczne PRO Femina
Czeladz Slaskie, 41-25, Poland More Info
Contact
48601434404
Pawel Gruenpeter
Principal Investigator
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Katowice Slaskie, 40-06, Poland More Info
Contact
48509230537
Maja Patalong-Ogiewa
Principal Investigator
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
Katowice Slaskie, 40-57, Poland More Info
Contact
48322062669
Maciej Maciejowski
Principal Investigator
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze Śląskie, 41-80, Poland More Info
Contact
48323704594
Monika Adamczyk-Sowa
Principal Investigator
Neurologicka Ambulancia s.r.o.
Banská Bystrica , 974 0, Slovakia More Info
Contact
421484124549
Beata Dupejova
Principal Investigator
Nemocnica Ruzinov
Bratislava , 826 0, Slovakia More Info
Contact
421905494172
Viera Hančinová
Principal Investigator
Queen's Medical Centre
Nottingham , NG7 2, United Kingdom More Info
Christopher Allen
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT06220669

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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