LY4298445 in healthy adults and people with lupus or rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial sponsored by Eli Lilly that examines the safety and tolerability of the investigational drug LY4298445 in both healthy volunteers and adults with SLE or RA. Participants will be enrolled at sites in Australia and China and will receive LY4298445 under controlled dosing regimens with regular safety monitoring. The study includes both healthy cohorts and disease cohorts to compare tolerability across populations, and participation can last up to approximately 52 weeks. Key outcomes focus on adverse events, tolerability measures, and pharmacokinetic data to inform later-stage trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Nucleus Network
  Brisbane, Australia Recruiting
• Nucleus Network
  Melbourne, Australia Recruiting
• Peking University First Hospital
  Beijing, China Not yet recruiting
• Peking University Third Hospital
  Beijing, China Not yet recruiting
• Xiangya Hospital of Central South University
  Changsha, China Not yet recruiting
• Anhui Provincial Hospital
  Hefei, China Not yet recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Test of HBM7020 in healthy adults and adults with autoimmune diseases

  This first-in-human study tests whether HBM7020 is safe and how it acts in the body for people with autoimmune diseases like RA, SLE, Sjögren's, and SSc compared with healthy volunteers.

  Recruiting Phase 1 Otsuka Pharmaceutical Development & Commercialization, Inc. · Brisbane, Queensland · NCT07649265

• ABBV-519 in adults with SLE or RA: safety and how the drug moves through the body after IV and subcutaneous doses

  This early study tests how ABBV-519 behaves in the body and its safety for adults with SLE or RA after single escalating doses.

  Recruiting at 15 sites Phase 1 AbbVie · Anniston, Alabama and 14 other locations · NCT07607964

• Anti-CD19/BCMA universal CAR-T cell therapy for refractory autoimmune diseases

  This will try anti-CD19/BCMA universal CAR-T cell therapy in adults with refractory rheumatoid arthritis, dermatomyositis, systemic lupus, or systemic sclerosis to see if it is safe and can control their disease.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07558850

• Immun4Cure Cohort of Autoimmune Diseases

  A long-term, 500-person database and biobank is being built to study autoimmune diseases like RA, SLE, and scleroderma, plus healthy adults, using deep profiling and regular follow-ups over five years.

  Recruiting University Hospital, Montpellier · Montpellier · NCT07515638

• MK-1045 for people with lupus or rheumatoid arthritis

  This research tests the experimental medicine MK-1045 to see if it is safe and tolerable in adults with lupus or rheumatoid arthritis.

  Recruiting at 20 sites Phase 1 Merck Sharp & Dohme LLC · Southport, Queensland and 20 other locations · NCT07363590

• Anti-CD19/BCMA U CAR-T cell therapy for relapsed or refractory autoimmune diseases

  This pilot will test whether anti-CD19/BCMA U CAR-T cells can help adults with relapsed or refractory autoimmune diseases such as SLE, systemic sclerosis, Sjögren's syndrome, and rheumatoid arthritis.

  Recruiting Early Phase 1 Changhai Hospital · Shanghai · NCT07246096

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.