Healthy, Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
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.
Interventions
DRUGLY4298445
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 52 | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic (PD): Degree of Peripheral B Cell Depletion Following Biopsy in Participants | Baseline up to Week 52 | PD: Peripheral B cell depletion |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4298445 | Baseline up to Approximately Week 57 | PK: AUC of LY4298445 |
| PK: Maximum Concentration (Cmax) of LY4298445 | Baseline up to Week 52 | PK: Cmax of LY4298445 |
Countries
Australia, China
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed