Phase 1 Lupus Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 65 years old who have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) according to recognised 2019 classification guidelines
• People whose lupus disease activity score (called SLEDAI) falls between 2 and 12, with some active clinical symptoms present
• People experiencing new or returning skin, mouth, or joint symptoms related to their lupus
• People who have been on a stable but insufficiently effective standard treatment plan before entering the study, including low-to-moderate dose steroid tablets (prednisone or equivalent, no more than 20mg per day for over 4 weeks) and/or one type of immune-suppressing medication at specified doses for more than 12 weeks (such as methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine); antimalarial medications are also permitted
• People with a body mass index (a measure of weight relative to height) between 18 and 35 at the time of screening
• People whose treating doctor has assessed them as medically suitable for a combination therapy involving a drug called Vunakizumab alongside steroids
• People who are willing and able to give written consent and have shown they can follow study requirements

Who may not be able to join:

• People whose lupus has caused serious damage to major organs, including brain or thinking problems, kidney failure, significant heart failure, or lung conditions such as pulmonary hypertension or interstitial lung disease
• People with currently active lupus involvement in specific organs, including the brain (lupus cerebritis), kidneys with significant protein in the urine, the heart muscle, the digestive system blood vessels, the lungs, or conditions affecting blood cell counts or the eyes
• People who also have another autoimmune condition — such as rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis — that could affect how results are measured
• People with liver problems, shown by certain blood test results being above acceptable levels
• People who have had any cancer in the past 5 years, or have a history of cancer
• People who have another health condition that requires ongoing steroid treatment, such as asthma or Crohn's disease
• People with active infections currently requiring treatment, including tuberculosis, hepatitis B, hepatitis C, HIV, or CMV
• People who have had major surgery within the 3 months before screening
• People who have a known allergy or sensitivity to the study drug (Vunakizumab)
• People who are pregnant, breastfeeding, or planning to become pregnant
• People who have received certain biological therapies (including anti-CD20 medicines, belimumab, or TNF-alpha inhibitors) within the 3 months before entering the study
• People who have received high-dose steroid treatment, plasma exchange, intravenous immunoglobulin (IVIG), or cyclophosphamide within the past 3 months
• People who have any other condition that the trial investigators believe could affect their safety or their ability to complete the study (confirm with trial site)

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