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 70 years old (inclusive), of any gender.
• People who weigh at least 45 kg.
• People who have been diagnosed with systemic lupus erythematosus (SLE — a long-term immune system condition) according to recognised medical classification criteria set in 1997.
• People whose SLE is considered active, with a disease activity score (SLEDAI-2K) of 6 or higher at the time of screening.
• People who have a specific type of lupus kidney disease (lupus nephritis), confirmed by a kidney biopsy taken within the past year or during the screening period, showing an active type III or type IV pattern (type V may also be present alongside these).
• People whose urine and kidney function tests during screening show a urine protein-to-creatinine ratio above 1.0 g/g, a 24-hour urine protein level of at least 1 g, and a kidney filtration rate (eGFR) of 60 mL/min/1.73 m² or higher.
• People whose blood test at the start of the trial shows a level of a particular immune protein (IFN-γ) above the normal upper limit.
• People whose immune cell ratio (Th1/Th2) in the blood at the start of the trial is 14 or higher.
• People who are not currently receiving induction therapy for SLE, or people who are receiving one of the following stable treatment regimens (confirm with trial site for full dose and duration requirements): oral prednisone (or equivalent steroid) alone; a permitted immunosuppressant drug alone (such as hydroxychloroquine, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, cyclosporine A, or tacrolimus); or a combination of oral steroids, hydroxychloroquine, and/or one permitted immunosuppressant — provided each has been taken at a stable dose for the required period before enrolment.
• People who are not pregnant and not breastfeeding during the trial.
• People who have no plans to become pregnant or to donate sperm or eggs within 6 months after screening and after the trial ends, and who agree to use effective contraception throughout.
• People who are willing to take part voluntarily, are able to sign an informed consent form, and are able to follow the trial requirements.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who have participated in another clinical trial within the past 3 months, or who are currently enrolled in one and have received a trial medication.
• People whose kidney filtration rate (eGFR) is below 60 mL/min/1.73 m², indicating more severe kidney impairment.
• People with serious neurological or psychiatric symptoms related to SLE, such as seizures, loss of consciousness, psychosis, confusion, meningitis, spinal cord problems, or movement disorders.
• People with a history of, or current diagnosis of, a significant blood vessel inflammation condition (vasculitis) unrelated to SLE, or whose condition overlaps significantly with another connective tissue disease.
• People with active skin conditions that could interfere with the evaluation of SLE, such as psoriasis, dermatomyositis, systemic sclerosis, or certain other skin conditions not caused by SLE.
• People who have had a lymph-related cancer (lymphoproliferative disease) in the past, or who have had or currently have any cancer in the past 5 years — with some exceptions for certain fully treated, non-recurring skin or cervical cancers (confirm with trial site).
• People with antiphospholipid syndrome (a clotting disorder) that is not well controlled.
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow or stem cell transplant.
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before screening, or who have wounds, ulcers, or fractures that have not fully healed.
• People who have received a live or weakened (attenuated) vaccine within 8 weeks before screening, or who plan to receive one during the trial.
• People who are allergic to the trial medication or its ingredients, or who have a history of severe allergic conditions or multiple allergies (such as to two or more medications, foods, or pollens), which the investigator considers a safety risk.
• People who have certain heart conditions at screening, including: moderate-to-severe heart failure (NYHA class III–IV); uncontrolled chest pain, heart failure, or a heart attack within the past 6 months; abnormal heart rhythm measurements on an ECG; certain types of heart conduction problems; conditions that increase the risk of abnormal heart rhythms; or a pumping function (ejection fraction) below 50%.
• People with active or latent (hidden) tuberculosis infection at screening.
• People with a serious active herpes virus infection at screening, such as herpes affecting the brain, widespread herpes, or herpes affecting the eyes.
• People who have needed to take oral or intravenous antibiotic or antiviral medication for an infection within 2 weeks before screening.
• People who were hospitalised for a serious opportunistic infection (an infection that occurs when the immune system is weakened) within 3 months before screening.
• People who have taken certain traditional Chinese herbal medicines, including Tripterygium Wilfordii preparations, within 4 weeks before screening.
• People with certain results on infectious disease screening, including: a positive hepatitis B surface antigen test; active hepatitis B virus detected in the blood (confirm with trial site for details); a positive hepatitis C antibody with confirmed active virus; a positive syphilis test where prior syphilis has not been confirmed as fully treated; or a positive HIV test.
• People with significantly abnormal liver, kidney, or blood test results at screening — including elevated liver enzymes, high bilirubin, elevated creatinine, low haemoglobin, low white blood cell or neutrophil counts, or low platelet counts (confirm with trial site for specific thresholds).
• People who have difficulty swallowing.
• People with a history of drug addiction or substance abuse.
• People who have an acute (sudden, short-term) illness before taking the trial medication.
• People who the investigator considers unsuitable for enrolment for any other reason.

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