Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07276958

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

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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