A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
- Registration Number
- NCT06220669
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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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.
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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.
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Have an Expanded Disability Status Scale (EDSS) score of less than or equal to (≤) 5.5 at screening and randomization.
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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).
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Meet criteria for neuromyelitis optica spectrum disorder (Wingerchuk and Lucchinetti 2022).
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Have a history of clinically significant central nervous system (CNS) disease.
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Have had a confirmed relapse with systemic corticosteroid administration <30 days prior to randomization.
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Have more than 20 active GdE brain lesions on screening MRI scan.
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Have received any of these medications or treatments.
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Have a current or recent acute, active infection.
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Have current serious or unstable illnesses.
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Have any other clinically important abnormality at screening or baseline.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3541860 Phase 2a Dose Level 1 LY3541860 LY3541860 will be given intravenously (IV) LY3541860 Phase 2b Dose Level 3 LY3541860 LY3541860 will be given IV. LY3541860 Phase 2a Dose Level 2 LY3541860 LY3541860 will be given IV. LY3541860 Phase 2b Dose Level 4 LY3541860 LY3541860 will be given IV. Placebo Phase 2a Placebo Placebo will be given IV. Placebo Phase 2b Placebo Placebo will be given IV.
- Primary Outcome Measures
Name Time Method Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions 12 Weeks Cumulative number will be measured by magnetic resonance imaging (MRI) scans.
- Secondary Outcome Measures
Name Time Method Cumulative Number of New and/or Enlarging T2 Lesions 12 Weeks Cumulative number will be measured by MRI scans.
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860 Baseline Through Week 12 Plasma trough concentrations of LY3541860 was measured.
Cumulative Number of Total Number of T1 GdE Lesions 12 Weeks Cumulative number will be measured by MRI scans.
Trial Locations
- Locations (54)
Universitatsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Healthcare Innovations Institute, LLC
🇺🇸Coral Springs, Florida, United States
Royal Palm Medical Group
🇺🇸Fort Myers, Florida, United States
Eastern Medical Group Research
🇺🇸Fort Myers, Florida, United States
Panhandle Research and Medical Clinic
🇺🇸Pensacola, Florida, United States
USF MS Center
🇺🇸Tampa, Florida, United States
Conquest Research LLC - Winter Park - ClinEdge - PPDS
🇺🇸Winter Park, Florida, United States
Consultants in Neurology
🇺🇸Northbrook, Illinois, United States
Sharlin Health and Neurology
🇺🇸Ozark, Missouri, United States
Psych Care Consultants Research
🇺🇸Saint Louis, Missouri, United States
Premier Neurology
🇺🇸Greer, South Carolina, United States
Hope Neurology
🇺🇸Knoxville, Tennessee, United States
ANRC Research
🇺🇸El Paso, Texas, United States
Prolato Clinical Research Center
🇺🇸Houston, Texas, United States
1960 Family Practice, PA
🇺🇸Houston, Texas, United States
Swedish Multiple Sclerosis Center
🇺🇸Seattle, Washington, United States
CHU Gui De Chauliac
🇫🇷Nîmes, Gard, France
CHRU de Nancy
🇫🇷Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Clermont Ferrand
🇫🇷Clermont-Ferrand, Puy-de-Dôme, France
Centre Hospitalier Intercommunal - Site de Poissy
🇫🇷Poissy, Yvelines, France
Studienzentrum für Neurologie und Psychiatrie
🇩🇪Böblingen, Baden-Württemberg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Nervenfachärztliche Gemeinschaftspraxis Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Klinikum Bayreuth GmbH
🇩🇪Bayreuth, Bayern, Germany
Institut für klinische Neuroimmunologie LMU Muenchen
🇩🇪München, Bayern, Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll
🇩🇪Bad Homburg, Hessen, Germany
Universitätsklinik Rostock
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Kaplan Medical Center
🇮🇱Rehovot, HaMerkaz, Israel
Galilee Medical Center
🇮🇱Nahariya, HaZafon, Israel
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto G. Giglio di Cefalù
🇮🇹Cefalù, Sicilia, Italy
Pauls Stradins Clinical Univeristy Hospital
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
🇱🇹Klaipėda, Klaipedos Apskritis, Lithuania
Neurocentrum Bydgoszcz sp. z o.o.
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Clinirem
🇵🇱Lublin, Lubelskie, Poland
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Mazowieckie, Poland
ETG Neuroscience - PPDS
🇵🇱Warszawa, Mazowieckie, Poland
Neurosphera SP. Z O.O
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Medyczne PRO Femina
🇵🇱Czeladz, Slaskie, Poland
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
🇵🇱Katowice, Slaskie, Poland
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
🇵🇱Katowice, Slaskie, Poland
Med-Polonia Sp. z o.o.
🇵🇱Poznan, Wielkopolskie, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
🇵🇱Poznan, Wielkopolskie, Poland
NEURO-MEDIC Sp. z o. o.
🇵🇱Katowice, Poland
ProNeuro Centrum Medyczne
🇵🇱Żory, Poland
IBISMED Wielospecjalistyczne Centrum Medyczne
🇵🇱Zabrze, Śląskie, Poland
Neurologicka Ambulancia s.r.o.
🇸🇰Banská Bystrica, Slovakia
Nemocnica Ruzinov
🇸🇰Bratislava, Slovakia
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom