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A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06220669
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	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)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Germany, Israel, Italy, Latvia, Lithuania, Poland, Slovakia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: LY3541860 Phase 2a Dose Level 1

LY3541860 will be given intravenously (IV)

Experimental: LY3541860 Phase 2a Dose Level 2

LY3541860 will be given IV.

Placebo Comparator: Placebo Phase 2a

Placebo will be given IV.

Experimental: LY3541860 Phase 2b Dose Level 3

LY3541860 will be given IV.

Experimental: LY3541860 Phase 2b Dose Level 4

LY3541860 will be given IV.

Placebo Comparator: Placebo Phase 2b

Placebo will be given IV.

Interventions

Drug: - LY3541860

Administered IV

Drug: - Placebo

Administered IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Healthcare Innovations Institute, LLC, Coral Springs, Florida

Status

Recruiting

Address

Healthcare Innovations Institute, LLC

Coral Springs, Florida, 33067

Site Contact

Clinical Trial Finder

A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Trial Details

Arms

Interventions

Contact a Trial Team

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