Multiple SclerosisPhase 2NCT06220669
A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
A Phase 2 study testing LY3541860 in people with Multiple Sclerosis, run by Eli Lilly and Company at 20 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- LY3541860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 19 Mar 2024to 13 Jul 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Poland9 sites
Neurocentrum Bydgoszcz sp. z o.o.
Bydgoszcz, 85-796
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
Katowice, 40-060
M.A. - LEK A.M. Maciejowscy SC. Centrum Terapii SM
Katowice, 40-571
NEURO-MEDIC Sp. z o. o.
Katowice, 40-686
Clinirem
Lublin, 20-064
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, 61-853
ETG Neuroscience - PPDS
Warsaw, 02-677
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, 41-800
ProNeuro Centrum Medyczne
Żory, 44-240
United States6 sites
Premier Neurology
Greer, South Carolina, 29605
Panhandle Research and Medical Clinic
Gulf Breeze, Florida, 32561
Hope Neurology
Knoxville, Tennessee, 37922
Consultants in Neurology
Northbrook, Illinois, 60062
Sharlin Health and Neurology
Ozark, Missouri, 65721-5315
Conquest Research LLC - Winter Park - ClinEdge - PPDS
Winter Park, Florida, 32789
Italy1 site
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Milan, 20133
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- LY3541860, Placebo
- Keywords
- Relapsing remitting multiple sclerosis, Clinically isolated syndrome, Secondary progressive multiple sclerosis with disease activity.
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3541860Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3541860 Phase 2a Dose Level 1 | Experimental | LY3541860 will be given intravenously (IV) Receives: Drug: LY3541860 |
| LY3541860 Phase 2a Dose Level 2 | Experimental | LY3541860 will be given IV. Receives: Drug: LY3541860 |
| Placebo Phase 2a | Placebo comparator | Placebo will be given IV. Receives: Drug: Placebo |
| LY3541860 Phase 2b Dose Level 3 | Experimental | LY3541860 will be given IV. Receives: Drug: LY3541860 |
| LY3541860 Phase 2b Dose Level 4 | Experimental | LY3541860 will be given IV. Receives: Drug: LY3541860 |
| Placebo Phase 2b | Placebo comparator | Placebo will be given IV. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Cumulative number will be measured by magnetic resonance imaging (MRI) scans.
Measured: 12 Weeks
Secondary outcomes (3)
Cumulative Number of Total Number of T1 GdE Lesions
Cumulative number will be measured by MRI scans.
Measured: 12 Weeks
Cumulative Number of New and/or Enlarging T2 Lesions
Cumulative number will be measured by MRI scans.
Measured: 12 Weeks
Pharmacokinetics (PK): Plasma Trough Concentrations of LY3541860
Plasma trough concentrations of LY3541860 was measured.
Measured: Baseline Through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start19 Mar 2024
- Primary completion18 Oct 2025
- Study completion13 Jul 2026
Why it stopped: The interim analysis data failed to demonstrate the intended treatment effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220669
- Sponsor's protocol ID
- 18548
- Other IDs
- J3K-MC-KIAB, 2023-503289-22-00, 2023
- Status last verified
- May 2026
- First submitted
- 15 Jan 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.