Phase 2 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 participants):

• People aged 18 to 75 years old
• People who are willing and able to sign a consent form and follow the study schedule and requirements
• Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use birth control or abstinence from 2 weeks before the first dose until 1 year after the last dose
• People taking steroid medications (such as prednisone) must be on a dose of 20 mg per day or less, and that dose must have been stable for at least 14 days before the screening visit
• People taking immune-suppressing or immune-modifying medications (other than steroids) must have been on a stable dose for at least 4 weeks before the screening visit
• People whose kidneys are functioning at a sufficient level, as measured by a specific blood test called eGFR (confirm with trial site)

People with Systemic Sclerosis (SSc / scleroderma):

• People who meet the recognised international medical classification for SSc
• People with either significant or worsening skin involvement (based on a specific skin scoring system), or moderate to severe lung scarring that is either severe enough or getting worse over time (confirm with trial site for exact scoring details)
• People whose SSc-related symptoms (other than Raynaud's phenomenon) began 10 years ago or less
• People who have not responded well enough to, or could not tolerate, at least one of these treatments: cyclophosphamide, methotrexate, mycophenolate mofetil/mycophenolic acid, nintedanib, rituximab, or tocilizumab

People with Inflammatory Muscle Disease (IIM / myositis):

• People who meet the recognised international medical classification for IIM
• People who test positive for at least one myositis-related antibody
• People whose muscle strength is below a certain level on a standard muscle testing score (confirm with trial site)
• People with elevated muscle enzyme levels in the blood and a doctor-assessed disease activity score above a certain level, plus at least one of the following: MRI scan, nerve conduction test, or muscle biopsy showing active muscle inflammation within the last 6 months, or significant disease activity in areas outside the muscles (confirm with trial site)
• People who have not responded well enough to at least 2 immune-suppressing treatments (including steroids) for 3 months or more, or who could not tolerate them

People with ANCA-Associated Vasculitis (AAV):

• People who meet the recognised international medical classification for either Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
• People whose AAV has come back or has not responded to immune-suppressing treatments, or whose disease can only be controlled with unacceptably high or repeated doses of steroids
• People who test positive for either PR3-ANCA or MPO-ANCA antibodies at screening
• People with a certain level of disease activity based on a standardised vasculitis scoring system (confirm with trial site)

People with Rheumatoid Arthritis (RA):

• People who have a confirmed diagnosis of RA meeting recognised international criteria
• People who test positive for Rheumatoid Factor (RF) or a specific protein antibody (ACPA)
• People with a CRP blood test result above 3 mg/L, indicating inflammation
• People who have not responded well enough to at least one standard disease-modifying drug (such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine), AND either at least two biologic medications with different ways of working, OR at least one biologic medication plus at least one targeted synthetic medication — but who have tried no more than three such biologic or targeted medications in total
• People with at least 6 swollen joints and 6 tender joints at assessment

Who may not be able to join:

General exclusions (all participants):

• People whose kidney function falls below a certain level as measured by an eGFR blood test
• People who are currently on kidney dialysis or expected to need it during the study
• People who have previously had an organ transplant or bone marrow transplant, or who are planning one during the study period
• People with a condition, either from birth or acquired, that seriously weakens the immune system and has caused severe infections, or who receive regular immunoglobulin replacement therapy
• People with liver disease or significant liver dysfunction, including cirrhosis or high bilirubin levels in the blood
• People with certain lung conditions, including COPD or asthma requiring daily oral steroids, low blood oxygen levels at rest, or a significant smoking history combined with active lung disease
• People with lung scarring (ILD) who need supplemental oxygen, or whose lung function has declined below certain levels on breathing tests (confirm with trial site)
• People with low blood cell counts not caused by their autoimmune disease, including low white blood cells, low red blood cells (anaemia), low neutrophils, or low platelets, or who have had a blood transfusion in the 60 days before starting treatment
• People with serious heart conditions, including uncontrolled chest pain, dangerous heart rhythm problems, a heart attack within the past 12 weeks, any prior coronary artery bypass surgery, severe heart failure, significantly reduced heart pumping function, an abnormal heart electrical reading above a certain level, or a serious blood clot event within the past 12 weeks (confirm with trial site)
• People with active bleeding disorders
• People with another overlapping autoimmune condition where that condition or its treatment could affect the study results, or with other significant kidney disease unrelated to the condition being studied
• People who are pregnant, breastfeeding, or of childbearing potential and not using adequate contraception
• People with a current infection requiring antibiotic or antiviral treatment, or who had a serious infection requiring treatment within the past 30 days
• People who test positive for HIV, Hepatitis B, or Hepatitis C, or who have active or latent tuberculosis requiring suppressive therapy
• People who have had major surgery within 28 days before starting treatment, or who have not fully recovered from a previous surgery
• People who have had a cancer diagnosis within the past 5 years (with some exceptions for certain treated skin cancers and treated cervical cell changes — confirm with trial site)
• People who have previously received cellular therapies such as CAR-T cells, CAR-NK cells, or mesenchymal cell therapy
• People with a significant neurological condition or an autoimmune disease affecting the brain or nervous system within the past 90 days, or signs of nervous system-related autoimmune activity within the past year

Additional exclusions for people with SSc:

• People with moderate to severe pulmonary arterial hypertension (high blood pressure in the lung arteries) requiring specific medication for it (people with mild, well-controlled pulmonary arterial hypertension may still be considered)
• People with severe gut movement problems requiring feeding directly into a vein
• People who have had a kidney crisis or fluid around the heart causing compression within the past 6 months
• People with current gangrene (tissue death) in a finger or toe

Additional exclusions for people with IIM:

• People with severe long-term muscle damage or significant muscle loss in major muscle groups, as shown on MRI scan (confirm with trial site for specific thresholds)
• People whose muscle strength score on a standard test falls at or below a certain low level (confirm with trial site)
• People whose muscle inflammation is caused by something other than IIM, such as inclusion body myositis, cancer-related myositis, muscular dystrophy, or certain overlap conditions with other rheumatological diseases (Sjögren's syndrome overlap is an exception)
• People with other serious generalised muscle or nerve-muscle conditions unrelated to IIM
• People with a specific type of muscle disease called immune-mediated necrotising myopathy

Additional exclusions for people with AAV:

• People with severe bleeding in the lungs requiring breathing support through a ventilator
• People who required dialysis or plasma exchange within the 12 weeks before screening
• People with another known disease that could interfere with the study assessments, such as eosinophilic GPA, anti-GBM disease, lupus, IgA vasculitis, rheumatoid vasculitis, or cryoglobulinaemic vasculitis

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