Phase 1 Lupus Trial, Recruiting NCT07276958 Sponsor: Eli Lilly and Company Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07276958
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Healthy volunteers:

  • You are between 18 and 55 years old and considered to be in good health.
  • You weigh at least 50 kg (about 110 lbs) and your body mass index (a measure of body weight relative to height) is between 18 and 32.

People with Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body's own tissues:

  • You are between 18 and 75 years old.
  • You weigh between 45 and 145 kg (about 99–320 lbs) and your BMI is between 18 and 35.
  • You received an official diagnosis of SLE, using recognised medical guidelines, at least 6 months before joining the study.

People with Rheumatoid Arthritis (RA) — a condition causing joint pain and swelling:

  • You are between 18 and 75 years old.
  • You weigh between 45 and 145 kg (about 99–320 lbs) and your BMI is between 18 and 35.
  • You were diagnosed with RA as an adult, using recognised medical guidelines, at least 6 months before joining the study.
  • Your RA disease activity score (a measure of how active your arthritis is) is at or above a certain level, based on a standard scoring system (confirm with trial site).
  • A blood test shows certain markers linked to RA (rheumatoid factor or anti-citrullinated peptide antibodies) are present.
  • You have already tried at least two advanced RA treatments (biological or targeted medicines) without adequate benefit, after also trying a more standard RA medicine first.

Who may not be able to join:

  • You have a known allergy to the study drug (LY4298445) or any of its ingredients.
  • You were assigned female at birth and are currently breastfeeding, or you test positive for pregnancy at screening.
  • You have severe, active kidney disease related to lupus, shown by high levels of protein in your urine, very low kidney function scores, or a need for dialysis within the past 6 months (confirm with trial site).
  • You have active lupus affecting your brain or nervous system — for example, seizures, psychosis, vision problems, or stroke — within the 2 months before joining the study.
  • Your rheumatoid arthritis has reached the most severe stage of physical disability, classified as "Class 4" by standard medical guidelines (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 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

Phone: 1-317-615-4559

Australian sites

Nucleus Network, Brisbane,
+617 3707 2720
Nucleus Network, Melbourne,
+61 1800 243 733

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
4 February 2026
Est. completion
1 March 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov