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
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Healthcare Innovations Institute, LLC
NOT_YET_RECRUITING
Coral Springs
Eastern Medical Group Research
NOT_YET_RECRUITING
Fort Myers
Royal Palm Medical Group
NOT_YET_RECRUITING
Fort Myers
Panhandle Research and Medical Clinic
RECRUITING
Gulf Breeze
High Quality Research
NOT_YET_RECRUITING
Miami
USF MS Center
NOT_YET_RECRUITING
Tampa
Conquest Research LLC - Winter Park - ClinEdge - PPDS
RECRUITING
Winter Park
Illinois
Consultants in Neurology
RECRUITING
Northbrook
Missouri
Sharlin Health and Neurology
RECRUITING
Ozark
Psych Care Consultants Research
NOT_YET_RECRUITING
St Louis
South Carolina
Premier Neurology
RECRUITING
Greer
Tennessee
Hope Neurology
RECRUITING
Knoxville
Texas
ANRC Research
NOT_YET_RECRUITING
El Paso
1960 Family Practice, PA
NOT_YET_RECRUITING
Houston
Prolato Clinical Research Center
NOT_YET_RECRUITING
Houston
Washington
Swedish Multiple Sclerosis Center
NOT_YET_RECRUITING
Seattle
Other Locations
France
Centre Hospitalier Universitaire de Clermont Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHRU de Nancy
NOT_YET_RECRUITING
Nancy
CHU Gui De Chauliac
NOT_YET_RECRUITING
Nîmes
Centre Hospitalier Intercommunal - Site de Poissy
RECRUITING
Poissy
Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll
NOT_YET_RECRUITING
Bad Homburg
Klinikum Bayreuth GmbH
NOT_YET_RECRUITING
Bayreuth
Studienzentrum für Neurologie und Psychiatrie
NOT_YET_RECRUITING
Böblingen
Universitatsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Institut für klinische Neuroimmunologie LMU Muenchen
NOT_YET_RECRUITING
München
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Nervenfachärztliche Gemeinschaftspraxis Ulm
NOT_YET_RECRUITING
Ulm
Israel
Galilee Medical Center
NOT_YET_RECRUITING
Nahariya
Kaplan Medical Center
NOT_YET_RECRUITING
Rehovot
Italy
Fondazione Istituto G. Giglio di Cefalù
NOT_YET_RECRUITING
Cefalù
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
RECRUITING
Milan
Ospedale San Raffaele S.r.l. - PPDS
NOT_YET_RECRUITING
Milan
Latvia
Pauls Stradins Clinical Univeristy Hospital
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
NOT_YET_RECRUITING
Kaunas
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
NOT_YET_RECRUITING
Klaipėda
Poland
Neurocentrum Bydgoszcz sp. z o.o.
RECRUITING
Bydgoszcz
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
RECRUITING
Katowice
NEURO-MEDIC Sp. z o. o.
NOT_YET_RECRUITING
Katowice
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
NOT_YET_RECRUITING
Katowice
Clinirem
RECRUITING
Lublin
Med-Polonia Sp. z o.o.
NOT_YET_RECRUITING
Poznan
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
NOT_YET_RECRUITING
Poznan
Centrum Medyczne NeuroProtect
NOT_YET_RECRUITING
Warsaw
ETG Neuroscience - PPDS
NOT_YET_RECRUITING
Warsaw
Neurosphera SP. Z O.O
NOT_YET_RECRUITING
Warsaw
IBISMED Wielospecjalistyczne Centrum Medyczne
RECRUITING
Zabrze
ProNeuro Centrum Medyczne
NOT_YET_RECRUITING
Żory
Slovakia
Nemocnica Ruzinov
RECRUITING
Bratislava
United Kingdom
Queen's Medical Centre
SUSPENDED
Nottingham
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2028-08
Participants
Target number of participants: 200
Treatments
Experimental: LY3541860 Phase 2a Dose Level 1
LY3541860 will be given intravenously (IV)
Experimental: LY3541860 Phase 2a Dose Level 2
LY3541860 will be given IV.
Placebo_comparator: Placebo Phase 2a
Placebo will be given IV.
Experimental: LY3541860 Phase 2b Dose Level 3
LY3541860 will be given IV.
Experimental: LY3541860 Phase 2b Dose Level 4
LY3541860 will be given IV.
Placebo_comparator: Placebo Phase 2b
Placebo will be given IV.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company