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:

General requirements (all conditions):

• Major organ function must meet minimum levels — including blood cell counts, liver function, kidney function (with some exceptions at the doctor's discretion), heart function showing the heart pumps adequately, and oxygen levels of 92% or above
• Women who could become pregnant must use a medically accepted form of contraception, or not be sexually active, during treatment and for at least 12 months after treatment ends
• The person joining (and their parent or guardian if they are a minor) must sign a written consent form showing they understand and agree to take part

Lupus (SLE) specifically:

• People aged 5 years or older
• Diagnosed with lupus based on recognised medical classification criteria (confirm with trial site)
• Has already tried standard treatments — including high-dose steroids plus at least one other immune-suppressing medication for at least 3 months — or cannot tolerate standard treatments, or cannot reduce steroid dose low enough after 6 months of treatment (all subject to doctor's assessment)
• Has a high level of lupus disease activity, measured by recognised scoring tools (confirm with trial site)
• Has not had a serious complication called macrophage activation syndrome in the month before screening
• Has had brain or nervous system symptoms from lupus requiring treatment in the 60 days before screening, such as seizures, psychosis, or stroke-like events

Steroid-resistant nephrotic syndrome (MDR-SRNS) specifically:

• People aged 3 years or older
• Diagnosed with steroid-resistant nephrotic syndrome according to 2021 international kidney disease guidelines
• Has already tried two standard medications with different mechanisms for at least 12 months without adequate response, or one calcineurin inhibitor for 3–6 months without remission, or cannot tolerate standard treatment — all subject to the doctor's assessment and informed consent
• Kidney biopsy has been done and confirmed a specific tissue type — either minimal change disease or focal segmental glomerulosclerosis

IgA nephropathy specifically:

• People aged 5 years or older
• IgA nephropathy confirmed by kidney biopsy
• Has been treated with a specific blood pressure medication type (ACE inhibitor or ARB) for at least 3 months, plus meets at least one of: having tried steroids and an immune-suppressing or biologic medication for 3 or more months with ongoing significant protein in the urine; or kidney function declining rapidly; or being unable to tolerate standard treatment (subject to doctor's assessment)
• Does not have another condition causing the kidney disease, and blood pressure is not uncontrolled

Systemic sclerosis (scleroderma) specifically:

• People aged 5 years or older
• Diagnosed with scleroderma based on 2013 recognised classification criteria
• Has a positive blood test for scleroderma-related antibodies
• Has a skin thickening score of 15 or above out of 51 on a recognised assessment tool
• Has already tried steroids plus at least one immune-suppressing or biologic medication for more than 3 months without significant improvement, or has rapidly progressing disease unresponsive to standard therapy, or cannot tolerate standard treatment — all subject to doctor's assessment and informed consent

ANCA-associated vasculitis specifically:

• People aged 5 years or older
• Diagnosed with ANCA-associated vasculitis (microscopic polyangiitis or granulomatosis with polyangiitis) according to recognised classification criteria
• Has received steroids combined with at least one immune-suppressing or biologic medication for at least 3 months without sustained remission, or has relapsed after remission, or has severe vasculitis not responding adequately to standard treatment — subject to doctor's assessment and informed consent
• Has evidence of currently active vasculitis, measured by an age-appropriate scoring tool, with a score of 10 or above (out of 63)

Who may not be able to join:

• People with a known severe allergy or serious reaction to any medications used in this trial, including cyclophosphamide or tocilizumab
• People with severe heart failure (classified as Grade III or IV)
• People with a history of congenital heart disease, a heart attack in the past 6 months, serious heart rhythm problems, significant fluid around the heart, serious heart muscle inflammation, or who require blood pressure-raising medications to maintain stable vital signs
• People with an infection that cannot be controlled or that requires active treatment at the time of screening
• People with active tuberculosis at the time of screening
• People with active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus (CMV) infections, based on blood test results
• People with a history of severe herpes infections such as herpes of the brain or eye, or widespread herpes; or who have had signs of a herpes or chickenpox/shingles infection in the 12 weeks before screening
• People with active disease affecting the brain or central nervous system at the time of screening
• People with a current or prior diagnosis of cancer or malignant disease
• People with a secondary or inherited immune deficiency condition
• People with a significant history of serious disease affecting the heart, hormones, blood, liver, immune system, metabolism, lungs, nerves, skin, mental health, kidneys, or other major organs — except where the condition is lupus itself
• People who have had a solid organ transplant or stem cell transplant in the 3 months before screening, or who have had a significant graft-versus-host disease reaction in the 2 weeks before screening
• People who have received a live vaccine in the 4 weeks before screening
• People with a positive pregnancy blood test
• People who have participated in another clinical trial and received any treatment within 3 months before joining
• People with abnormal lab results that the doctor considers clinically significant enough to prevent safe participation
• People where the doctor judges that participation may increase risk or affect trial results

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