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 Systemic Lupus Erythematosus (SLE/lupus) based on recognised medical classification systems.
• You have been taking steroids together with immune-suppressing medications and/or biologic treatments for at least 2 months before the screening visit, and your doses have been stable for more than 2 weeks, but your lupus is still active.
• Your blood tests at screening show at least one of certain lupus-related antibodies (ANA, anti-ds-DNA, or anti-Smith antibody).
• Your lupus disease activity scores, as measured by your doctor using standard medical scoring tools (SLEDAI-2K and BILAG2004), are above certain thresholds, meaning your disease is considered active enough to qualify.
• Your doctor has rated your overall disease activity as at least a 1 out of 3 on a standard assessment scale.

Who may not be able to join:

• You have another autoimmune disease that requires ongoing treatment throughout your whole body.
• You have had a severe, uncontrolled lupus crisis in the 8 weeks before screening, such as severe kidney, nerve, blood, heart, or lung complications caused by lupus.
• You have a significant brain or nervous system condition that is not caused by lupus, such as a stroke, epilepsy, dementia, Parkinson's disease, or psychosis.
• You have had a bone marrow, stem cell, or organ transplant in the past, or are planning to have one.
• You have had a serious heart problem in the past 12 months, such as heart failure (moderate to severe), a heart attack, unstable chest pain, or certain heart rhythm problems.
• You have significant heart or lung symptoms such as inflammation around the heart or fluid around the lungs at the time of screening, if the doctor considers this makes the trial unsuitable for you.
• You have severe asthma or severe chronic obstructive pulmonary disease (COPD) — though mild or moderate cases that are stable on treatment may still qualify (confirm with trial site).
• You have had a cancer diagnosis within the past 5 years, with some exceptions for certain fully treated skin cancers or early-stage cancers with no remaining disease.
• You are currently pregnant or breastfeeding.
• You have a history of repeated serious infections requiring hospital stays and intravenous antibiotics (for example, 3 or more of the same type of infection in the past year).
• You have had an active infection requiring treatment throughout your whole body in the 2 weeks before the clearance visit, such as pneumonia or tuberculosis.
• You have tested positive for Hepatitis B, Hepatitis C, HIV, or syphilis in specific ways outlined by the trial (confirm with trial site).
• You have received a live vaccine within 4 weeks before the clearance visit, or plan to receive one during the study.
• You have received high-dose steroids (prednisone 60 mg/day or more) within 4 weeks before the clearance visit, or you are unable to reduce your steroid dose to a lower level before that visit.
• You are unable to reduce or stop certain background medications before the start of the trial, as required by the trial protocol (confirm with trial site).
• You have been on kidney dialysis or a similar kidney replacement treatment in the 3 months before screening, or expect to need it during the study.
• You have had a problem with drug or alcohol misuse in the past year.
• You have had thoughts of suicide in the past 6 months, or any suicidal behaviour in the past 12 months, that your doctor considers a significant risk.
• You have taken part in another clinical drug trial within 4 weeks (or longer, depending on the medication) before screening.
• You have had a severe allergic or life-threatening reaction to any component of the study treatment in the past.
• Your doctor believes any other health condition you have could affect your safety or the results of the study.

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