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:

• People aged between 18 and 80 years old
• People who are in good general health, or who have been diagnosed with Systemic Lupus Erythematosus (SLE/lupus) using a recognised set of medical classification standards
• People willing to sign a consent form and take part in all parts of the study for its full duration
• People taking a steroid medication called prednisone at a dose of 10 mg per day or less, with that dose stable for at least 2 weeks before the screening visit and kept the same through the start of the trial
• People whose regular lupus medications have been stable for at least 4 weeks before screening and remain unchanged through the start of the trial
• People who show certain abnormal results on at least one of the following tests measuring blood vessel stiffness or inflammation: a cardio-ankle vascular index (CAVI) test, a pulse wave velocity (PWV) test, or a specialised imaging scan called an FDG PET CT (confirm with trial site for exact thresholds)
• People whose medications for diabetes, high blood pressure, and/or cholesterol (statins) have been stable for at least the past 3 months, with no changes to these or to immune-suppressing medications planned during the trial
• People of reproductive potential who agree to use highly effective contraception from screening through to 16 weeks after the last dose of study medication (abstinence is also accepted as effective contraception for this study)
• People who have previously been vaccinated against COVID-19 and chickenpox (Varicella Zoster), confirmed by verbal confirmation and detectable antibodies in the blood if vaccination records are unavailable

Who may not be able to join:

• People who have any health condition that, in the investigator's opinion, could affect how the study drug is evaluated or how results are interpreted
• People who are currently enrolled in another clinical trial involving an investigational treatment
• People who had major surgery within 8 weeks before signing the consent form, or who have planned major surgery during the study period
• People whose screening blood or urine tests show certain abnormal results, including problems with liver function, kidney function, protein in the urine, low white blood cell count, low platelet count, low red blood cell levels, or — for people with diabetes — poorly controlled blood sugar; or people who test positive for COVID-19, flu A or B, or RSV at screening (note: some abnormal results may be re-tested once within 4 weeks — confirm with trial site)
• People taking certain immune-suppressing medications above specific dose limits, including azathioprine above 200 mg/day, mycophenolate mofetil above 3 g/day, methotrexate above 25 mg/week, mizoribine above 150 mg/day, leflunomide above 20 mg/day, or other immunosuppressants at the investigator's discretion
• People who have received any investigational drug (experimental treatment) within 4 weeks or 5 half-lives before the start of the trial, whichever is longer
• People who have received any approved biologic medicine within 5 half-lives before signing the consent form
• People who have received B-cell depleting therapies (such as rituximab, belimumab, or similar medicines) within 26 weeks before signing the consent form, or within 40 weeks for a specific medicine called atacicept
• People who have received steroid injections into a joint, muscle, or vein within 4 weeks before the trial start, or any live or weakened vaccine within 8 weeks before signing the consent form
• People who have had thoughts of suicide in the past 6 months, or any suicidal behaviour in the past 12 months
• People who have had a heart attack or stroke within the past year before the trial start
• People whose lupus is currently active, with a disease activity score (SLEDAI-2K) above 6 at screening
• People with active severe or unstable lupus affecting the brain or nervous system that would prevent full understanding of the consent form, or that the investigator believes requires more aggressive treatment than the study allows
• People with active severe lupus affecting the kidneys that the investigator believes requires more aggressive treatment than the study allows
• People with a history of, or current diagnosis of, severe antiphospholipid syndrome (a blood clotting condition) within 1 year before signing the consent form — though people with this condition that has been well controlled by blood-thinning medication for at least 3 months may still be considered
• People with a known history of a primary immune system deficiency, removal of the spleen, or any condition that makes them particularly prone to infections; or people who test positive for HIV at screening (people who decline HIV testing during screening are also not eligible)
• People who test positive for hepatitis B surface antigen or hepatitis B core antibody (with further testing required depending on results — confirm with trial site)
• People who test positive for both hepatitis C antibody and detectable hepatitis C virus in the blood
• People with a history of severe herpes infections at any time, including herpes that spread throughout the body, herpes affecting the brain, repeated shingles (2 or more episodes within 2 years), or herpes affecting the eye
• People who have had a shingles, CMV (cytomegalovirus), or Epstein-Barr virus infection that has not fully resolved within 12 weeks before signing the consent form
• People who have had a significant ongoing infection within 8 weeks before the trial start, an infection requiring hospitalisation or intravenous antibiotics that was not completed at least 4 weeks before the trial start, or any infection requiring oral antibiotics or antiviral medicines within 2 weeks before the trial start (unless taking these preventatively)
• People with a history of cancer, except for certain treated skin cancers resolved at least 3 months before the trial start, or certain treated cervical conditions resolved at least 1 year before the trial start
• People who are pregnant, breastfeeding, or planning to become pregnant at any point from screening through to the end of the study
• People who have had a miscarriage, termination, stillbirth, or live birth within 4 weeks before the trial start, or who are pregnant within that time
• People with known allergies to any ingredient in the study drug, or a history of severe allergic reaction (anaphylaxis) to any human immunoglobulin (antibody-based) therapy
• People who have tested positive for COVID-19 on the day of screening or within the 21 days before screening

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