A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220669
• Other study ID #: 18548
• Secondary ID: J3K-MC-KIAB2023-
• Status: Recruiting
• Phase: Phase 2
• Start date: March 19, 2024
• Est. completion date: August 2028

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• LY3541860
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Clermont Ferrand	Clermont-Ferrand	Puy-de-Dôme
France	CHRU de Nancy	Nancy	Meurthe-et-Moselle
France	CHU Gui De Chauliac	Nîmes	Gard
France	Centre Hospitalier Intercommunal - Site de Poissy	Poissy	Yvelines
Germany	Zentrum für klinische Forschung Dr. med. Irma Schöll	Bad Homburg	Hessen
Germany	Klinikum Bayreuth GmbH	Bayreuth	Bayern
Germany	Studienzentrum für Neurologie und Psychiatrie	Böblingen	Baden-Württemberg
Germany	Universitatsklinikum Leipzig	Leipzig	Sachsen
Germany	Klinikum Großhadern, LMU	München	Bayern
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Universitätsklinik Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Germany	Nervenfachärztliche Gemeinschaftspraxis Ulm	Ulm	Baden-Württemberg
Israel	Barzilai Medical Center	Ashkelon
Israel	Galilee Medical Center	Nahariya	HaZafon
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Italy	Fondazione Istituto G. Giglio di Cefalù	Cefalù	Sicilia
Italy	Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas	Kauno Apskritis
Lithuania	Klaipeda Hospital, Affiliate of Klaipeda University Hospital	Klaipeda	Klaipedos Apskritis
Poland	Neurocentrum Bydgoszcz sp. z o.o.	Bydgoszcz	Kujawsko-Pomorskie
Poland	Centrum Medyczne PRO Femina	Czeladz	Slaskie
Poland	M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM	Katowice	Slaskie
Poland	Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala	Katowice	Slaskie
Poland	Prywatny Gabinet Lekarski U. Chyrchel-Paszkiewicz	Lublin	Lubelskie
Poland	Centrum Medyczne NeuroProtect	Warszawa	Mazowieckie
Poland	IBISMED Wielospecjalistyczne Centrum Medyczne	Zabrze	Slaskie
Slovakia	Neurologicka Ambulancia s.r.o.	Banská Bystrica
Slovakia	Nemocnica Ruzinov	Bratislava
United Kingdom	Queen's Medical Centre	Nottingham
United States	Healthcare Innovations Institute, LLC	Coral Springs	Florida
United States	Premier Neurology	Greer	South Carolina
United States	Hope Neurology	Knoxville	Tennessee
United States	Consultants In Neurology	Northbrook	Illinois
United States	Sharlin Health and Neurology	Ozark	Missouri
United States	Swedish Multiple Sclerosis Center	Seattle	Washington
United States	USF MS Center	Tampa	Florida
United States	Conquest Research LLC - Winter Park - ClinEdge - PPDS	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  France,  Germany,  Israel,  Italy,  Latvia,  Lithuania,  Poland,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions	Cumulative number will be measured by magnetic resonance imaging (MRI) scans.	12 Weeks
Secondary	Cumulative Number of Total Number of T1 GdE Lesions	Cumulative number will be measured by MRI scans.	12 Weeks
Secondary	Cumulative Number of New and/or Enlarging T2 Lesions	Cumulative number will be measured by MRI scans.	12 Weeks
Secondary	Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860	Plasma trough concentrations of LY3541860 was measured.	Baseline Through Week 12

External Links

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