Phase 2 Vasculitis Trial, Recruiting

Written by an AI model from the 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 aged 18 or older who have been diagnosed with a form of vasculitis that is limited to the skin, such as isolated cutaneous small or medium vessel vasculitis, cutaneous polyarteritis nodosa, or IgA vasculitis (previously called Henoch-Schönlein purpura) without significant or worsening kidney involvement.
• People whose vasculitis diagnosis has been confirmed by a skin biopsy before joining the trial, which must have included a specific immune-staining test (immunofluorescence) if small vessel vasculitis was suspected.
• People who have had continuously active skin vasculitis for at least one month, or who have experienced two or more flares in the six months before joining.
• People who have visible, active vasculitis lesions on their skin at the time of joining (fading marks or healing wounds on their own do not count as active disease).
• People who have already tried one of the three study medications but could not tolerate it or did not respond to it, or who have a medical reason to avoid one of the study drugs — these people may be able to enter the trial at a later stage, though the number of such participants is limited (confirm with trial site).
• People who have previously taken or are currently taking steroid tablets (such as prednisone) for their skin vasculitis, provided they are able to taper and stop steroids within six weeks of starting the study drug.
• People taking a low, stable dose of steroids (5 mg per day or less of prednisone or equivalent) for a separate condition, such as asthma or adrenal insufficiency, may be considered if a dose increase is unlikely to be needed during the six-month study period.
• People with mild symptoms such as joint aches, muscle pain, mild leg swelling, tiredness, low-grade fever, slight weight loss (no more than around 3 kg in the past three months), or mild anaemia (haemoglobin of 10 g/dL or above) may still be considered eligible.

Who may not be able to join:

• People who have significant vasculitis or inflammatory disease affecting organs beyond the skin, such as the kidneys, lungs, nervous system, or other major organ systems.
• People diagnosed with a known systemic form of vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, or central nervous system vasculitis, or people who test positive for ANCA antibodies on blood testing.
• People whose skin vasculitis is known to be caused by another underlying condition, such as lupus, Sjögren's syndrome, another autoimmune disease, a cancer, a blood disorder, an active infection, or a medication.
• People with a known history of serious intolerance, allergy, or severe side effects to any of the study medications — though these people may be considered for a later stage of the trial involving only the other medications (confirm with trial site).
• People who have a medical reason to avoid two or all three of the study drugs, or who have already tried two or all three of the study drugs without success or had to stop them due to side effects.
• People who have a deficiency of an enzyme called G6PD, or who have a history of a type of anaemia caused by red blood cell breakdown (haemolytic anaemia) — all participants are tested for G6PD before joining, and those with this deficiency may still be considered for a later stage of the trial using only the other two medications (confirm with trial site).
• People known to have low or absent activity of an enzyme called TPMT — these people may still be considered for a later stage of the trial using only the other two study medications (confirm with trial site).
• People with significant liver disease or liver function test results more than twice the normal upper limit.
• People with significant kidney disease or a kidney filtration rate below 60 mL/min.
• People with significant or symptomatic anaemia, or a haemoglobin level below 10 g/dL.
• People with another health condition that is likely to require repeated courses of steroid tablets during the study period, such as severe or unstable asthma or chronic obstructive pulmonary disease (COPD).
• People with an active cancer, or a history of cancer within the past five years (people in remission for more than five years, those with non-spreading prostate cancer, or those who have been treated for certain non-spreading skin cancers may still be considered — confirm with trial site).
• People with a serious or uncontrolled active infection that could make taking the study medications unsafe.
• People who are not able to give informed consent to participate.
• People who are pregnant or breastfeeding.

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