Actively Recruiting
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Led by Eli Lilly and Company · Updated on 2026-04-17
63
Participants Needed
7
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 55 years
- Healthy participants must weigh at least 50 kg and have a BMI between 18 and 32 kg/m8
- SLE participants aged 18 to 75 years
- SLE participants must weigh 45 to 145 kg and have a BMI between 18 and 35 kg/m8
- SLE diagnosis confirmed by 2019 EULAR/ACR criteria at least 6 months before screening
- RA participants aged 18 to 75 years
- RA participants must weigh 45 to 145 kg and have a BMI between 18 and 35 kg/m8
- Adult-onset RA diagnosis for at least 6 months based on 2010 ACR/EULAR criteria
- RA participants must have DAS28-hsCRP score of 4.4 or higher
- RA participants must test positive for rheumatoid factor or anti-citrullinated peptide antibodies
- RA participants must have failed at least 2 advanced therapies after conventional DMARD treatment
You will not qualify if you...
- Known allergies to LY4298445, related compounds, or any formulation components
- Female participants assigned at birth who are lactating or have a positive pregnancy test at screening or Day -1
- Severe active lupus kidney disease with urine protein/creatinine ratio above 200 mg/mmol or estimated glomerular filtration rate below 40 mL/min/1.73 m8
- Requirement for hemodialysis within 6 months before screening
- Active central nervous system lupus with symptoms such as seizure, psychosis, organic brain syndrome, visual disturbances, cranial nerve disorder, lupus headache, or stroke within 2 months before screening
- Rheumatoid arthritis classified as Class 4 by ACR revised criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Nucleus Network
Brisbane, Australia, 4006
Actively Recruiting
2
Nucleus Network
Melbourne, Australia, VIC 3004
Actively Recruiting
3
Peking University First Hospital
Beijing, China, 100034
Not Yet Recruiting
4
Peking University Third Hospital
Beijing, China, 100191
Not Yet Recruiting
5
Xiangya Hospital of Central South University
Changsha, China, 410008
Not Yet Recruiting
6
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200127
Not Yet Recruiting
7
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430022
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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