Phase 1 Vasculitis 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 between 18 and 65 years old (inclusive), of any gender
• People whose bone marrow, liver, kidneys, blood clotting, and heart function all meet minimum health thresholds set by the trial (confirm specific values with trial site)
• People who are able and willing to use reliable contraception or abstain from sex during treatment and for at least 12 months after, if there is any chance of pregnancy occurring
• Women who are not pregnant (confirmed by a blood test within 7 days before enrolling) and who are not breastfeeding
• People willing to take part voluntarily and sign a consent form

Plus, people must also have one of the following specific conditions:

• People diagnosed with systemic lupus erythematosus (SLE) whose disease has not responded to, or has come back after, multiple standard treatments — and who also have either kidney involvement with significant protein in the urine, confirmed by a kidney biopsy within the last 6 months, or a very low platelet count that has not improved with standard treatments
• People diagnosed with Sjögren's syndrome whose disease remains active or has returned despite at least 6 months of standard treatment, who have a disease activity score of 6 or higher on a standard medical scale, and who test positive for a specific antibody called anti-SSA/Ro
• People diagnosed with systemic sclerosis (scleroderma) whose disease remains active or has returned despite at least 6 months of standard treatment, who test positive for related antibodies, and who have widespread skin involvement or active lung disease — OR whose skin or lung disease is progressing rapidly
• People diagnosed with inflammatory myopathy (such as dermatomyositis, polymyositis, antisynthetase syndrome, or necrotising myopathy) whose disease remains active or has returned despite at least 6 months of standard treatment, who test positive for related antibodies, and who have measurable muscle weakness or active lung disease — OR whose muscle or lung condition is worsening
• People diagnosed with ANCA-associated vasculitis (a type of blood vessel inflammation) whose disease remains active or has returned despite at least 6 months of standard treatment, who test positive for specific antibodies, and who score 15 or above on a standard vasculitis activity scale
• People diagnosed with antiphospholipid syndrome who meet recognised diagnostic criteria, test positive for specific antibodies on at least two occasions 12 weeks apart, and whose blood clots have returned despite standard anticoagulation therapy — OR who have the severe form of this condition (catastrophic antiphospholipid syndrome) involving three or more organs

Who may not be able to join:

• People with a history of severe drug allergies or a general tendency toward allergic reactions
• People who have an active infection, or a suspected infection that is not fully controlled, caused by bacteria, viruses, fungi, or other organisms
• People with central nervous system conditions not caused by their underlying disease (such as epilepsy, organic brain disorders, stroke, or encephalitis unrelated to their condition)
• People whose heart function is not strong enough to safely undergo the trial treatment
• People born with immune system conditions that affect the body's ability to produce antibodies (immunoglobulin deficiencies)
• People who have had a cancer diagnosis within the past 5 years
• People with complete kidney failure (end-stage renal failure)
• People who test positive for hepatitis B with detectable virus in the blood, or who test positive for active hepatitis C, HIV, or syphilis
• People who have had a blood clot in a deep vein or in the lungs within the 6 months before the screening visit
• People with a psychiatric disorder or severe difficulties with thinking or memory
• People who have taken part in another clinical trial within the 3 months before enrolling
• People who have recently received certain immunosuppressive or biological medicines within defined timeframes before enrolling (confirm specific timeframes with trial site)
• People who are pregnant or planning to become pregnant
• People whom the trial doctors determine are unsuitable for other reasons

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