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 are willing to take part voluntarily, have been fully informed about the study, have signed a consent form, and are able to follow all study procedures.
• People aged 18 to 75 years old (inclusive) at the time of signing the consent form, of any sex.
• People who have been diagnosed with primary membranous nephropathy (a kidney condition) within the past 5 years before the screening visit.
• People who have a kidney biopsy result confirming primary membranous nephropathy, or who have nephrotic syndrome (a kidney disorder causing protein loss) along with a positive blood test for anti-PLA2R antibodies within the past 6 months — and who also meet at least one of the following: protein in the urine above 8 g per 24 hours, OR kidney function (eGFR) at or above 60 mL/min/1.73 m² with urine protein above 3.5 g per 24 hours. People in this group should also have been on the highest tolerated dose of certain blood pressure/kidney-protecting medicines (ACEIs or ARBs) for at least 3 months before screening, unless those medicines were not suitable for them (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test at the screening visit.
• Women who could become pregnant, and male participants, must agree to use effective contraception from the time of signing the consent form until 12 months after their last dose of the trial medicine.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or who have a positive pregnancy blood test before being assigned to a treatment group.
• Women who could become pregnant, or partners of male participants, who plan to become pregnant during the study period.
• People with a history of drug or alcohol misuse within the past year before screening.
• People who have been diagnosed with, or are suspected of having, a cancer within the past 5 years — except for certain limited skin or cervical cancers that were treated with no signs of return (confirm with trial site).
• People who have previously had an organ transplant, or a stem cell or bone marrow transplant, or who plan to have one during the study.
• People who have a primary immune deficiency condition, or Type 1 diabetes, or Type 2 diabetes — unless a kidney biopsy taken within the past year shows that diabetes has not damaged the kidneys (confirm with trial site).
• People who have serious or poorly controlled conditions affecting the heart, blood, lungs, digestive system, hormones, nervous system, mental health, skin, muscles and joints, or immune system, where the treating doctor believes this would affect safety or the study results.
• People who have end-stage kidney disease and need a transplant or dialysis, or who produce very little urine (less than 400 mL per day) at screening or before being assigned to a treatment group.
• People who have an active, recurring, or long-term infection at the time of screening, including conditions such as tuberculosis, certain viral or fungal infections (confirm with trial site).
• People who required antibiotic or antiviral treatment by injection, or who needed to be hospitalised for an infection, within the 2 months before being assigned to a treatment group.
• People whose lung scan or chest X-ray at screening shows signs of current or past tuberculosis infection.
• People who have abnormal heart rhythm results on an ECG at screening, specifically a QTc interval above 450 ms for males or above 470 ms for females (confirm with trial site).
• People with certain abnormal blood test results at screening, including: low red blood cell levels (haemoglobin below 90 g/L), low platelets, or low white blood cells; elevated liver enzymes or bilirubin; kidney filtration rate (eGFR) below 30 mL/min/1.73 m²; abnormal blood clotting results (if not on blood thinners); a positive result on a tuberculosis blood test; positive HIV test; positive syphilis test; active hepatitis B or C infection (confirm with trial site for exact values).
• People with a history of serious allergic reactions to two or more medicines, to the specific trial medicines (HLX01 or HLX79) or their ingredients, to contrast dyes used in scans, or to human or animal proteins or antibody-based medicines.
• People who have recently used certain medicines that affect the immune system, including: steroids or mycophenolate within 1 month; calcineurin inhibitors (such as tacrolimus or cyclosporine) or other immunosuppressants within 3 months; chemotherapy agents such as cyclophosphamide within 6 months before being assigned to a treatment group — or who are expected to need these medicines during the study.
• People who have received certain targeted immune therapies (such as rituximab, belimumab, JAK inhibitors, or similar medicines) within the past year — unless they received a B-cell depleting drug and blood tests show their B-cell levels have returned to normal (confirm with trial site).
• People who have received intravenous immunoglobulin or plasma exchange within the 3 months before being assigned to a treatment group.
• People who have taken part in another clinical drug trial too recently (within 1 month or within 5 half-lives of the previous trial medicine, whichever is longer), or who plan to join another drug trial before completing this one.
• People who have taken part in a surgical or medical device trial within the past 3 months, or who plan to do so during this study.
• People who have received a live or live-attenuated vaccine (such as certain flu or travel vaccines) within the past 3 months, or who plan to receive one during the study.
• People who are unable or unwilling to have repeated blood draws, or for whom it is difficult to access a vein.
• People who have donated or lost more than 400 mL of blood within the 2 months before screening, or who plan to donate blood during the study.
• People where the trial doctor has a clear reason to believe that joining the study would not be in their best interests.

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