Testing LY4298445 Safety in Healthy People and Those With Lupus or Arthritis
Tests LY4298445 for safety in healthy adults and people with lupus or rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Key facts
- Where
- Shinjuku-ku, JapanSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07276958, who can take part
Where in Japan
- Clinical Research Hospital TokyoShinjuku-ku, JapanNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07276958EU 2026-527207-25-00
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 known allergies to LY4298445, related compounds, or any components of the formulation; 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; Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1; Have a Class 4 RA according to the ACR revised criteria.