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 who have signed a written consent form to participate
• People aged 14 to 65 years (inclusive), of any gender
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) according to a standard set of medical diagnostic guidelines (the 1997 ACR criteria)
• People who have had a kidney biopsy in the past six months confirming a moderate-to-severe form of lupus kidney disease (known as class III, IV, or V lupus nephritis)
• People whose lupus disease activity score (SLE-DAI) is greater than 6, indicating active disease
• People whose urine protein levels are above 1.0 g per day, indicating the kidneys are leaking protein

Who may not be able to join:

• People whose kidney filtering function (measured by a test called eGFR) is at or above 45 ml/min/1.73 m²
• People who have received kidney replacement therapy, plasma exchange, immunoadsorption, or a high dose of intravenous immunoglobulin in the past 2 months
• People who have serious damage to a vital organ or a lupus crisis (such as lung bleeding, brain complications, or heart failure) that the trial doctor considers unsuitable for participation
• People with certain abnormal blood count results — such as low white blood cells, low neutrophils, low lymphocytes, or low platelets — unless those abnormalities are caused directly by active lupus
• People with significantly abnormal liver function test results (ALT, AST, or bilirubin more than twice the normal upper limit)
• People with a known allergy or medical reason to avoid the study medications belimumab and/or telitacicept
• People who have an active infection or have required intravenous antibiotics within the past month
• People who are pregnant or currently breastfeeding
• People who currently have, or have had within the past 3 months: active hepatitis B, hepatitis C, tuberculosis, a viral lung infection called cytomegalovirus pneumonia, active fungal infection, syphilis, or HIV; an active stomach or intestinal ulcer; a history of drug or alcohol misuse; or severe malnutrition (defined as a BMI below 16 kg/m²)
• People with certain serious ongoing health conditions, including: a potentially life-threatening heart or cardiovascular condition; chronic obstructive pulmonary disease (COPD); asthma or significant allergic conditions requiring long-term steroid tablets; severely high blood pressure (malignant hypertension); or a history of cancer in the past 5 years (with exceptions for certain fully treated skin cancers or cervical pre-cancer — confirm with trial site)
• People whom the trial doctor considers unsuitable for any other reason

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