Phase 1 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:

General requirements (all participants must meet these):

• People aged 18 to 65 years old, of any gender.
• People whose blood, liver, kidney, and heart function meet minimum health levels set by the trial (specific lab test results will be checked by the trial site).
• People who are able and willing to use reliable contraception during the trial and for at least 12 months after treatment ends; women who could become pregnant must have a negative pregnancy blood test within 7 days before joining, and must not be breastfeeding.
• People who are willing to participate voluntarily and sign a consent form agreeing to follow the trial requirements.

Disease-specific requirements (participants must also meet the criteria for their specific condition):

Systemic Lupus Erythematosus (SLE) — a disease where the immune system attacks the body's own tissues:

• People who have been formally diagnosed with SLE using recognised international medical criteria.
• People whose SLE has not responded to standard treatments, specifically those who have either: kidney involvement (lupus nephritis) that has not improved after treatment with steroids and at least two other immune-suppressing medicines, with protein levels in urine remaining high and a kidney biopsy confirming a specific type of kidney damage within the past 6 months; or very low platelet counts (a blood clotting problem linked to SLE) that have not responded to steroid treatment combined with at least one other immune-suppressing medicine for at least 3 months.

Sjögren's Syndrome — a condition where the immune system attacks moisture-producing glands:

• People who have been formally diagnosed with primary Sjögren's syndrome using recognised international medical criteria.
• People whose disease activity score (measured using a specific medical tool called ESSDAI) is 6 or higher, indicating moderately active disease.
• People who test positive for a specific antibody called anti-SSA/Ro.
• People whose condition has continued to be active or has come back after at least 6 months of standard treatment with steroids combined with one or more immune-suppressing or biological medicines.

Systemic Sclerosis (also called scleroderma) — a condition causing hardening of the skin and sometimes internal organs:

• People who have been formally diagnosed with systemic sclerosis using recognised international medical criteria from 2013.
• People who test positive for antibodies associated with systemic sclerosis.
• People who have widespread skin hardening or active lung involvement shown on a specific type of lung scan (HRCT).
• People whose condition has continued to be active or has returned despite at least 6 months of standard treatment with steroids and cyclophosphamide, combined with one or more other immune-suppressing medicines; OR people whose condition is progressing rapidly, shown by significant worsening of skin scores or lung function measurements.

Inflammatory Myopathy — a group of conditions causing muscle inflammation and weakness:

• People who have been formally diagnosed with an inflammatory muscle disease (such as dermatomyositis, polymyositis, antisynthetase syndrome, or necrotizing myopathy) using recognised international medical criteria from 2017.
• People who test positive for antibodies specifically associated with muscle inflammation.
• People who show significant muscle weakness based on a standardised muscle strength test, along with at least two other abnormal health measurements; OR people with less severe muscle weakness but who have active lung disease shown on a specific type of lung scan (HRCT).
• People whose condition has continued to be active or has returned despite at least 6 months of standard treatment; OR people whose condition is getting worse, including rapidly worsening lung disease.

ANCA-Associated Vasculitis — a condition where the immune system causes inflammation in small blood vessels:

• People who have been formally diagnosed with a type of ANCA-associated vasculitis (microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis) using recognised international criteria from 2022.
• People who test positive for specific antibodies linked to vasculitis (either MPO-ANCA or PR3-ANCA).
• People whose disease activity score (measured using a specific medical tool called BVAS) is 15 or higher, indicating active vasculitis.
• People whose condition has continued to be active or has returned despite at least 6 months of standard treatment with steroids and immune-suppressing medicines.

Antiphospholipid Syndrome — a condition where the immune system increases the risk of blood clots:

• People who have been formally diagnosed with primary antiphospholipid syndrome using recognised international criteria from 2006.
• People who test positive for specific antiphospholipid antibodies at medium to high levels on at least two separate occasions within a 12-week period.
• People who have experienced a return of blood clots despite being on standard blood-thinning treatment (such as warfarin or heparin), and who have also previously received steroids and cyclophosphamide; OR people who have a severe form of the condition called catastrophic antiphospholipid syndrome, involving three or more organs affected within one week, confirmed by tissue testing, with antiphospholipid antibodies present.

Who may not be able to join:

• People with a history of serious allergic reactions to medicines, or who are known to react strongly to many substances.
• People who have a current or suspected infection (such as a bacterial, viral, or fungal infection) that is not fully under control.
• People who have brain or nervous system conditions not caused by their underlying autoimmune disease (confirm with trial site).
• People whose heart function is not strong enough to safely handle the trial treatment.
• People who were born with an immune system condition that prevents normal antibody production.
• People who have had a cancer diagnosis within the past 5 years.
• People whose kidneys have failed completely (end-stage kidney failure).
• People who test positive for active hepatitis B, hepatitis C, HIV, or syphilis infections meeting specific criteria checked by the trial site.
• People who have had a blood clot in a deep vein or in the lungs within the 6 months before joining the trial.
• People with a diagnosed psychiatric condition or significant problems with thinking, memory, or understanding.
• People who have taken part in another clinical trial within the 3 months before joining this trial.
• People who have recently received certain immune-suppressing medicines or biological medicines within specific time periods before joining (confirm exact timeframes with trial site).
• People who are currently pregnant or planning to become pregnant.
• People whom the trial doctors consider unsuitable for the trial for other medical reasons.

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