“A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis”

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

5 Jul 2024 → 15 Dec 2025

Decision date (initial)

2024-05-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eli Lilly and Co.

External identifiers

EU CT number

2023-503289-22-00

WHO UTN

U1111-1287-5424

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Dose response, Safety, Pharmacodynamic, Efficacy

To evaluate the efficacy of LY3541860 versus placebo on the number of new T1 GdE MRI brain lesions in participants with RMS

Conditions and MedDRA coding

Relapsing Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions Cumulative number will be measured by magnetic resonance imaging (MRI) scans

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 6

Locations

7 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 174 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications