A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

NCT ID: NCT07276958

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-03-31

Brief Summary

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.

Conditions

Healthy; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

LY4298445 (Part A2)

SAD of LY4298445 administered SC in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)

Group Type: EXPERIMENTAL

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445 (Part B)

Multiple-ascending doses (MAD) of LY4298445 administered SC in participants with SLE or RA

Group Type: EXPERIMENTAL

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445 (Part C)

Single dose of LY4298445 administered SC in healthy Japanese and Chinese participants

Group Type: EXPERIMENTAL

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445 Placebo (Part C)

Single dose of LY4298445 administered SC in healthy Japanese and Chinese participants

Group Type: PLACEBO_COMPARATOR

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445 (Part A1)

Single-ascending dose (SAD) of LY4298445 administered subcutaneously (SC) or intravenously (IV) in healthy participants

Group Type: EXPERIMENTAL

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445

Intervention Type: DRUG

Administered IV

LY4298445 Placebo (Part A1)

SAD of LY4298445 administered SC or IV in healthy participants

Group Type: PLACEBO_COMPARATOR

LY4298445

Intervention Type: DRUG

Administered SC

LY4298445

Intervention Type: DRUG

Administered IV

Interventions

LY4298445

Administered SC

Intervention Type: DRUG

LY4298445

Administered IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy participants between the ages of 18 and 55 years.

• Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m²), inclusive.

Participants with Systemic Lupus Erythematosus (SLE)

• Are 18 to 75 years of age, inclusive.
• Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.
• Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 6 months prior to screening.

Participants with Rheumatoid Arthritis (RA)

• Are 18 to 75 years of age, inclusive.
• Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.
• Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR/EULAR classification criteria
• Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 4.4.
• Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies
• Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug [bDMARD] or targeted synthetic DMARD [tsDMARD]) after failing a conventional synthetic DMARD (csDMARD).

Exclusion Criteria

• Have known allergies to LY4298445, related compounds, or any components of the formulation
• Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.
• Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and/or by

• urine protein/creatinine ratio greater than 200 milligrams per millimole (mg/mmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or
• an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL/min)/1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.
• requiring hemodialysis within 6 months prior to screening
• Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening
• Have a Class 4 RA according to the ACR revised criteria

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Nucleus Network

Brisbane, , Australia

Countries

Australia

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)

Role: CONTACT

LillyTrials@Lilly.com

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

clinical_inquiry_hub@lilly.com

Facility Contacts

Role: primary

+617 3707 2720

Other Identifiers

J6S-MC-KCAA

Identifier Type: OTHER

Identifier Source: secondary_id

27747

Identifier Type: -

Identifier Source: org_study_id