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:

• Adults aged 18 to 75 years at the time of signing the consent form (the minimum age may vary in some countries based on local rules)
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 6 months before joining, and whose diagnosis meets a recognised 2019 international classification standard
• People whose SLE is showing a certain level of active disease activity at the screening stage, as measured by two standard medical scoring tools used to assess lupus (confirm with trial site)
• People who are already receiving at least one approved SLE treatment — such as low-dose steroid tablets, hydroxychloroquine, quinacrine, or certain immune-suppressing medicines — at doses within limits set by the trial, and who have been on a stable dose for a required period before joining
• People who are willing and able to give written consent and follow all parts of the trial plan

Who may not be able to join:

• Women who are pregnant or breastfeeding at the time of screening or at the start of the trial
• Women who are able to become pregnant and have not been using a highly effective form of contraception in the 28 days before joining, or who do not agree to continue using one throughout the trial and for 28 days after finishing the study drug (women using an oral contraceptive pill will also need to use an additional barrier method during the trial and for 28 days after stopping the study drug)
• Men who have not had a confirmed vasectomy, if their female partner is able to become pregnant and is not willing to use a highly effective contraceptive throughout the trial and for a set period after stopping the study drug; sperm donation is also not permitted during this time
• People whose lupus was caused by a medication they were taking (known as drug-induced lupus)
• People with active or unstable lupus affecting the brain or nervous system
• People who have another autoimmune condition alongside SLE (such as rheumatoid arthritis, Crohn's disease, multiple sclerosis, or certain others) that could affect how SLE is assessed — though some related conditions secondary to SLE may still be considered (confirm with trial site)
• People with any significant finding from a chest X-ray, eye examination, heart tracing (ECG), vital signs check, or blood test at screening that the trial doctor believes could affect safety or interfere with the trial
• People whose blood test results at screening show liver enzyme levels more than three times the normal upper limit, a very low white blood cell count, a very low platelet count, or a low haemoglobin level indicating significant anaemia
• People with significant kidney problems, based on specific urine or blood test results at screening (confirm with trial site)
• People who have received a vaccine within 2 weeks before starting the study drug (or within 4 weeks for live or live-attenuated vaccines)
• People who have previously received or are currently receiving gene therapy for SLE, such as CAR-T cell therapy
• People who are currently in another clinical trial or have taken an investigational drug or used an investigational device within 28 days (or longer, depending on the drug) before signing consent
• People who have had a serious infection requiring hospital admission or intravenous antibiotics or antiviral treatment within 4 weeks before starting the study drug, or who have active tuberculosis
• People whose chest X-ray at screening shows signs suggesting a history of tuberculosis
• People who test positive or have an unclear result for tuberculosis on a specific blood test at screening
• People who have an abnormally prolonged heart rhythm interval (QTc) on an ECG at screening or at the start of the trial, or who have risk factors for a serious heart rhythm problem (such as heart failure, low potassium levels, or a family history of a heart condition called Long QT Syndrome), or who are taking other medicines known to affect this heart measurement
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People with any other medical or mental health condition that, in the trial doctor's opinion, would make it unsafe for them to complete the trial
• People who have planned surgery requiring general, spinal, or epidural anaesthesia during the trial period (minor surgery under local anaesthesia that does not require an overnight hospital stay may be considered on a case-by-case basis)
• People who test positive for HIV at screening
• People who test positive for active Hepatitis B or Hepatitis C virus infection at screening
• People who have a psychotic disorder or unstable mood disorder, as shown by use of antipsychotic medication within the 2 years before screening
• People with a history of drug or alcohol dependency or misuse within the 2 years before screening
• People with a current or past history of cancer, lymphoma, leukaemia, or related blood or lymph system conditions (except for certain skin cancers or cervical cancer that have been fully treated by surgery)
• People who the trial investigators consider unsuitable for participation for any other reason

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