A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: LY3541860; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06220669

2023-503289-22-00 (Other Identifier)

J3K-MC-KIAB (Other Identifier)

18548

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 6 patient groups, including a placebo group

LY3541860 Phase 2a Dose Level 1

Experimental group

Description:

LY3541860 will be given intravenously (IV)

Treatment:

Drug: LY3541860

LY3541860 Phase 2a Dose Level 2

Experimental group

Description:

LY3541860 will be given IV.

Treatment:

Drug: LY3541860

Placebo Phase 2a

Placebo Comparator group

Description:

Placebo will be given IV.

Treatment:

Drug: Placebo

LY3541860 Phase 2b Dose Level 3

Experimental group

Description:

LY3541860 will be given IV.

Treatment:

Drug: LY3541860

LY3541860 Phase 2b Dose Level 4

Experimental group

Description:

LY3541860 will be given IV.

Treatment:

Drug: LY3541860

Placebo Phase 2b

Placebo Comparator group

Description:

Placebo will be given IV.

Treatment:

Drug: Placebo