Clinical trial NCT06220669: A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
timeFrame: 12 Weeks
Secondary outcomes:
measure: Cumulative Number of Total Number of T1 GdE Lesions
timeFrame: 12 Weeks
measure: Cumulative Number of New and/or Enlarging T2 Lesions
timeFrame: 12 Weeks
measure: Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860
timeFrame: Baseline Through Week 12
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: Healthcare Innovations Institute, LLC
state: Florida
city: Fort Myers
country: United States
facility: Royal Palm Medical Group
state: Florida
city: Fort Myers
country: United States
facility: Eastern Medical Group Research
state: Florida
city: Pensacola
country: United States
facility: Panhandle Research and Medical Clinic
state: Florida
city: Tampa
country: United States
facility: USF MS Center
state: Florida
city: Winter Park
country: United States
facility: Conquest Research LLC - Winter Park - ClinEdge - PPDS
state: Florida
city: Northbrook
country: United States
facility: Consultants in Neurology
state: Illinois
city: Ozark
country: United States
facility: Sharlin Health and Neurology
state: Missouri
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Greer
country: United States
facility: Premier Neurology
state: South Carolina
city: Knoxville
country: United States
facility: Hope Neurology
state: Tennessee
city: El Paso
country: United States
facility: ANRC Research
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: 1960 Family Practice, PA
state: Texas
city: Seattle
country: United States
facility: Swedish Multiple Sclerosis Center
state: Washington
city: Nîmes
country: France
facility: CHU Gui De Chauliac
state: Gard
city: Nancy
country: France
facility: CHRU de Nancy
state: Meurthe-et-Moselle
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand
state: Puy-de-Dôme
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal - Site de Poissy
state: Yvelines
city: Böblingen
country: Germany
facility: Studienzentrum für Neurologie und Psychiatrie
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Nervenfachärztliche Gemeinschaftspraxis Ulm
state: Baden-Württemberg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
state: Bayern
city: München
country: Germany
facility: Institut für klinische Neuroimmunologie LMU Muenchen
state: Bayern
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung Dr. med. Irma Schöll
state: Hessen
city: Rostock
country: Germany
facility: Universitätsklinik Rostock
state: Mecklenburg-Vorpommern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center
state: HaZafon
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
state: Lombardia
city: Cefalù
country: Italy
facility: Fondazione Istituto G. Giglio di Cefalù
state: Sicilia
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
state: Kauno Apskritis
city: Klaipėda
country: Lithuania
facility: Klaipeda Hospital, Affiliate of Klaipeda University Hospital
state: Klaipedos Apskritis
city: Bydgoszcz
country: Poland
facility: Neurocentrum Bydgoszcz sp. z o.o.
state: Kujawsko-Pomorskie
city: Lublin
country: Poland
facility: Clinirem
state: Lubelskie
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Warszawa
country: Poland
facility: ETG Neuroscience - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Neurosphera SP. Z O.O
state: Mazowieckie
city: Czeladz
country: Poland
facility: Centrum Medyczne PRO Femina
state: Slaskie
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
state: Slaskie
city: Katowice
country: Poland
facility: M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
state: Slaskie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
state: Wielkopolskie
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
state: Wielkopolskie
city: Katowice
country: Poland
facility: NEURO-MEDIC Sp. z o. o.
city: Żory
country: Poland
facility: ProNeuro Centrum Medyczne
city: Zabrze
country: Poland
facility: IBISMED Wielospecjalistyczne Centrum Medyczne
state: Śląskie
city: Banská Bystrica
country: Slovakia
facility: Neurologicka Ambulancia s.r.o.
city: Bratislava
country: Slovakia
facility: Nemocnica Ruzinov
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: