New drug takes aim at autoimmune diseases in early human test
NCT ID NCT07276958
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-stage study tests an experimental drug called LY4298445 in healthy volunteers and people with lupus or rheumatoid arthritis. The main goal is to check safety and how the body handles the drug. Participants will receive either the drug or a placebo, and the study lasts up to about a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4298445 (an experimental drug given as an injection)
- What this could lead to
- If successful, this could point toward a new treatment option for lupus and rheumatoid arthritis by targeting immune cells.
- What could go wrong
- This is a very early Phase 1 trial with only 63 participants, so safety and effectiveness are not yet known. The drug may cause side effects or fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Hospital
NOT_YET_RECRUITINGHefei, 230036, China
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Nucleus Network
RECRUITINGBrisbane, 4006, Australia
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Nucleus Network
RECRUITINGMelbourne, VIC 3004, Australia
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Peking University First Hospital
NOT_YET_RECRUITINGBeijing, 100034, China
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, 100191, China
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Renji Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITINGShanghai, 200127, China
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The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, 325000, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, 430022, China
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Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, 410008, China
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