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 must be 18 years of age or older.
• Your blood counts and organ function (bone marrow, liver, and kidneys) must meet certain minimum health levels — your doctor can check these with blood tests.
• If you could become pregnant, you must have a negative pregnancy test within 7 days before joining and must not be breastfeeding; all participants who could father or become pregnant must agree to use reliable contraception (or abstain) during the study and for at least 6 months after it ends.
• You must be willing to sign a consent form, follow the study schedule, and attend follow-up visits.

You may also need to have one of the following specific diagnoses:

• Systemic Lupus Erythematosus (SLE): A confirmed SLE diagnosis with high disease activity or significant kidney involvement, where at least 6 months of standard treatments have not worked or the disease has come back after a period of improvement.
• Systemic Sclerosis (Scleroderma): A confirmed scleroderma diagnosis with certain antibodies in your blood, skin thickening or active lung disease, where standard treatments over 6 months have not worked, the disease has returned, or is rapidly getting worse (skin or lungs).
• Inflammatory Myopathy (muscle inflammation conditions): A confirmed diagnosis of an inflammatory muscle disease (such as dermatomyositis or polymyositis), with measurable muscle weakness and at least two other signs of active disease, where standard treatments have not worked, the disease has returned, or is rapidly progressing (confirm with trial site).
• ANCA-Associated Vasculitis (blood vessel inflammation): A confirmed diagnosis of a specific type of vasculitis with positive related antibodies and a high disease activity score, where standard treatments have not worked or the disease has returned.
• Connective Tissue Disease-related low platelet count: A confirmed connective tissue disease (such as lupus or Sjögren's syndrome) with a dangerously low platelet count, confirmed by a bone marrow test, where at least one course of strong steroid treatment combined with other medicines for at least 3 months has not worked.

Who may not be able to join:

• People with a history of serious allergic reactions to medications or who are known to have strong allergic tendencies.
• People who have an active infection (bacterial, viral, fungal, or other) that is not controlled or needs treatment.
• People who have brain or nervous system conditions related to or separate from their autoimmune disease (such as epilepsy, psychosis, stroke, or brain inflammation).
• People with serious heart problems or poor heart function.
• People born with an immune system condition that means they cannot produce normal antibodies (immunoglobulin deficiency).
• People who have had cancer at any point in the past 5 years.
• People with complete kidney failure (though people whose kidney problems are caused by lupus nephritis may still be considered — confirm with trial site).
• People who test positive for active Hepatitis B, Hepatitis C, HIV, or syphilis infections.
• People with serious psychiatric (mental health) conditions or significant memory/cognitive problems.
• People who have taken part in another clinical trial in the past 3 months.
• People who have recently taken immunosuppressant drugs or biologic medicines within a specific timeframe before joining (confirm exact timing with trial site).
• Women who are pregnant or planning to become pregnant during the study.
• Anyone the trial doctors feel is unsuitable for other reasons (confirm with trial site).

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