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:

• You are between 18 and 65 years old (inclusive), of any gender
• Your blood counts meet minimum levels — specifically, your white blood cell count and hemoglobin are above certain thresholds, without recent use of white blood cell boosting injections (confirm with trial site)
• Your liver function tests are within acceptable ranges (some allowance is made if your condition is causing the elevation)
• Your kidneys are working at a minimum level, based on a standard calculation of kidney function (confirm with trial site)
• Your blood clotting results are within an acceptable range
• Your heart and circulation are stable
• If you are able to have children (male or female), you agree to use medically approved contraception or abstain from sex during the trial and for at least 12 months after treatment ends
• If you are a woman who could become pregnant, you have had a negative pregnancy blood test within 7 days before joining, and you are not currently breastfeeding
• You are willing to take part voluntarily and have signed a consent form

You must also have one of the following conditions that has not responded well to standard treatments:

• Lupus (SLE) — diagnosed by recognised criteria, with either kidney involvement (lupus nephritis) or a very low platelet count (SLE-ITP) that has not improved despite multiple medications including steroids and at least two other treatments
• Sjögren's syndrome — diagnosed by recognised criteria, with a disease activity score of 6 or above, a positive blood test for anti-SSA/Ro antibodies, and the condition has continued or returned despite more than six months of standard treatment
• Systemic sclerosis (scleroderma) — diagnosed by recognised criteria, with a positive related antibody test, and either widespread skin thickening or active lung involvement, and the condition has continued, returned, or is progressing rapidly despite more than six months of standard treatment
• Inflammatory muscle disease (myositis) — diagnosed by recognised criteria, with a positive myositis-related antibody test, and either significant muscle weakness with abnormal test results, or active lung involvement, and the condition has continued, returned, or is worsening despite more than six months of standard treatment
• ANCA-associated vasculitis — diagnosed by recognised criteria, with a positive ANCA blood test, a vasculitis activity score of 15 or above, and the condition has continued or returned despite more than six months of standard treatment
• Antiphospholipid syndrome — diagnosed by recognised criteria, with moderate to high levels of antiphospholipid antibodies on at least two tests, and either blood clots have recurred despite standard blood-thinning treatment, or you have a severe form involving three or more organs within one week (confirm with trial site)

Who may not be able to join:

• People with a history of serious allergic reactions to medications, or who are generally prone to allergies
• People with an active or suspected infection (bacterial, viral, fungal, or other) that is not controlled
• People with central nervous system conditions (unless those conditions were caused by the underlying disease being studied) (confirm with trial site)
• People whose heart cannot safely tolerate the treatments involved in this study
• People born with immune system deficiencies affecting immunoglobulins (a type of immune protein)
• People who have had a cancer diagnosis within the past five years
• People with end-stage kidney failure
• People who test positive for active hepatitis B, hepatitis C, HIV, or syphilis (confirm with trial site for specific details)
• People who have had a blood clot in a deep vein or in the lungs within the six months before screening
• People with psychiatric disorders or severe problems with memory or thinking
• People who have taken part in another clinical trial within the past three months
• People who have recently taken immunosuppressive medicines or certain biological treatments (specific timeframes apply — confirm with trial site)
• Women who are pregnant or planning to become pregnant
• Anyone the trial doctor believes should not participate for other medical reasons

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