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

NCT ID
NCT07276958
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Eli Lilly and Company
Conditions
Healthy, Rheumatoid Arthritis, Systemic Lupus Erythematosus

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis

Enrollment: 68 participants (Estimated).

What is being studied

  • Drug: LY4298445

Who may be eligible

Ages
18 Years to 55 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: Healthy Participants 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 3.2. * 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

Study locations

10 study locations are listed.

Recruiting site status is explicitly provided for 10 locations; 2 are listed as Recruiting.

Countries: Australia, China, Japan

Sample of listed locations

  • Nucleus Network — Brisbane, 4006, Australia — Recruiting
  • Nucleus Network — Melbourne, VIC 3004, Australia — Recruiting
  • Peking University First Hospital — Beijing, 100034, China — Not yet recruiting
  • Peking University Third Hospital — Beijing, 100191, China — Not yet recruiting
  • Xiangya Hospital of Central South University — Changsha, 410008, China — Not yet recruiting
  • Anhui Provincial Hospital — Hefei, 230036, China — Not yet recruiting
  • Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, 200127, China — Not yet recruiting
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, 325000, China — Not yet recruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, 430022, China — Not yet recruiting
  • Clinical Research Hospital Tokyo — Shinjuku-ku, 160-0004, Japan — Not yet recruiting

Study details

Start date
February 4, 2026
Primary completion date
March 1, 2028
Completion date
March 1, 2028
First posted
December 11, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07276958
Registry last updated
October 8, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07276958 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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