Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with cutaneous lupus (lupus affecting the skin) with a skin activity score of 8 or higher on a specific measurement scale called CLASI-A.
• You have at least one active skin lesion of a specific type — either discoid lupus (DLE) or subacute cutaneous lupus (SCLE).
• If you have also been diagnosed with systemic lupus (SLE), your blood test must show a positive antinuclear antibody (ANA) result at a certain level (1:80 or higher) when tested at the trial's laboratory.
• If you have SLE, you must meet specific international diagnosis standards for SLE set by two major medical organisations (confirm with trial site).
• If you have SLE, you must currently be taking at least one approved SLE medication at a steady, unchanged dose.

Who may not be able to join:

• Your infection history or certain blood/lab test results raise safety concerns, in the opinion of the study doctor.
• You have moderate or severe liver disease (classified as Child-Pugh category B or C).
• Your lupus was caused by a medication (drug-induced lupus), rather than occurring on its own.
• You have a history of, or currently have, inflammatory joint or skin conditions other than SLE or cutaneous lupus.
• You have been diagnosed with certain other autoimmune conditions that could interfere with the study results (confirm with trial site for the specific list).
• You currently have severe or unstable lupus affecting your nervous system or mental health.
• You were hospitalised for a serious lupus flare in the past 3 months, or you currently have severe active lupus affecting organs such as the kidneys, that the study doctor feels cannot be safely managed within the trial.
• You have a current or past diagnosis of antiphospholipid syndrome (a clotting disorder linked to lupus).
• You have taken steroid tablets or injections for more than 2 weeks in total (for a condition other than lupus) within the past 24 weeks before starting the trial.
• You have a history of certain serious infections, or have recently been hospitalised for an infection or received intravenous antibiotic or antifungal treatment within specific timeframes (confirm with trial site).
• Your cancer screening results are concerning, or you have had cancer within a certain period of time — although some exceptions may apply for people who have been fully treated for certain skin cancers or cervical cancer in situ (confirm with trial site).
• You are currently taking certain medications that are not allowed during this trial (confirm with trial site for the specific list).

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