NCT06220669

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
1mo left

Started Mar 2024

Geographic Reach
7 countries

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2024Jul 2026

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 15, 2024

Last Update Submit

March 25, 2026

Conditions

Multiple Sclerosis

Keywords

Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.

Outcome Measures

Primary Outcomes (1)

  • Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

    Cumulative number will be measured by magnetic resonance imaging (MRI) scans.

    12 Weeks

Secondary Outcomes (3)

  • Cumulative Number of Total Number of T1 GdE Lesions

    12 Weeks

  • Cumulative Number of New and/or Enlarging T2 Lesions

    12 Weeks

  • Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860

    Baseline Through Week 12

Study Arms (6)

LY3541860 Phase 2a Dose Level 1

EXPERIMENTAL

LY3541860 will be given intravenously (IV)

Drug: LY3541860

LY3541860 Phase 2a Dose Level 2

EXPERIMENTAL

LY3541860 will be given IV.

Drug: LY3541860

Placebo Phase 2a

PLACEBO COMPARATOR

Placebo will be given IV.

Drug: Placebo

LY3541860 Phase 2b Dose Level 3

EXPERIMENTAL

LY3541860 will be given IV.

Drug: LY3541860

LY3541860 Phase 2b Dose Level 4

EXPERIMENTAL

LY3541860 will be given IV.

Drug: LY3541860

Placebo Phase 2b

PLACEBO COMPARATOR

Placebo will be given IV.

Drug: Placebo

Interventions

LY3541860DRUG

Administered IV

LY3541860 Phase 2a Dose Level 1LY3541860 Phase 2a Dose Level 2LY3541860 Phase 2b Dose Level 3LY3541860 Phase 2b Dose Level 4
PlaceboDRUG

Administered IV

Placebo Phase 2aPlacebo Phase 2b

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Panhandle Research and Medical Clinic

Gulf Breeze, Florida, 32561, United States

Location

Conquest Research LLC - Winter Park - ClinEdge - PPDS

Winter Park, Florida, 32789, United States

Location

Consultants in Neurology

Northbrook, Illinois, 60062, United States

Location

Sharlin Health and Neurology

Ozark, Missouri, 65721-5315, United States

Location

Premier Neurology

Greer, South Carolina, 29605, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

Centre Hospitalier Intercommunal - Site de Poissy

Poissy, 78303, France

Location

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3

Milan, 20133, Italy

Location

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

Location

Neurocentrum Bydgoszcz sp. z o.o.

Bydgoszcz, 85-796, Poland

Location

Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

Katowice, 40-060, Poland

Location

M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM

Katowice, 40-571, Poland

Location

NEURO-MEDIC Sp. z o. o.

Katowice, 40-686, Poland

Location

Clinirem

Lublin, 20-064, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, 61-853, Poland

Location

ETG Neuroscience - PPDS

Warsaw, 02-677, Poland

Location

IBISMED Wielospecjalistyczne Centrum Medyczne

Zabrze, 41-800, Poland

Location

ProNeuro Centrum Medyczne

Żory, 44-240, Poland

Location

Nemocnica Ruzinov

Bratislava, 826 06, Slovakia

Location

Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

March 19, 2024

Primary Completion

November 12, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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.
Access Criteria
research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

SL(1)IT(1)LA(1)FR(1)GB(1)PL(9)US(6)