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| ID | Type | Description | Link |
|---|---|---|---|
| J3K-MC-KIAB | Other Identifier | Eli Lilly and Company | |
| 2023-503289-22-00 | Other Identifier | EU Trial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3541860 Phase 2a Dose Level 1 | Experimental | LY3541860 will be given intravenously (IV) |
|
| LY3541860 Phase 2a Dose Level 2 | Experimental | LY3541860 will be given IV. |
|
| Placebo Phase 2a | Placebo Comparator | Placebo will be given IV. |
|
| LY3541860 Phase 2b Dose Level 3 | Experimental | LY3541860 will be given IV. |
|
| LY3541860 Phase 2b Dose Level 4 | Experimental | LY3541860 will be given IV. |
|
| Placebo Phase 2b | Placebo Comparator | Placebo will be given IV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3541860 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions | Cumulative number will be measured by magnetic resonance imaging (MRI) scans. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Number of Total Number of T1 GdE Lesions | Cumulative number will be measured by MRI scans. | 12 Weeks |
| Cumulative Number of New and/or Enlarging T2 Lesions | Cumulative number will be measured by MRI scans. |
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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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panhandle Research and Medical Clinic | Gulf Breeze | Florida | 32561 | United States | ||
| Conquest Research LLC - Winter Park - ClinEdge - PPDS |
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| Label | URL |
|---|---|
| Related Info | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered IV |
|
| 12 Weeks |
| Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860 | Plasma trough concentrations of LY3541860 was measured. | Baseline Through Week 12 |
| Winter Park |
| Florida |
| 32789 |
| United States |
| Consultants in Neurology | Northbrook | Illinois | 60062 | United States |
| Sharlin Health and Neurology | Ozark | Missouri | 65721-5315 | United States |
| Premier Neurology | Greer | South Carolina | 29605 | United States |
| Hope Neurology | Knoxville | Tennessee | 37922 | United States |
| Centre Hospitalier Intercommunal - Site de Poissy | Poissy | 78303 | France |
| Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3 | Milan | 20133 | Italy |
| Pauls Stradins Clinical Univeristy Hospital | Riga | LV-1002 | Latvia |
| Neurocentrum Bydgoszcz sp. z o.o. | Bydgoszcz | 85-796 | Poland |
| Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala | Katowice | 40-060 | Poland |
| M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM | Katowice | 40-571 | Poland |
| NEURO-MEDIC Sp. z o. o. | Katowice | 40-686 | Poland |
| Clinirem | Lublin | 20-064 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy | Poznan | 61-853 | Poland |
| ETG Neuroscience - PPDS | Warsaw | 02-677 | Poland |
| IBISMED Wielospecjalistyczne Centrum Medyczne | Zabrze | 41-800 | Poland |
| ProNeuro Centrum Medyczne | Żory | 44-240 | Poland |
| Nemocnica Ruzinov | Bratislava | 826 06 | Slovakia |
| Queen's Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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