Phase 2 Uveitis 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 to 65 years old (inclusive) who weigh at least 45 kg, of any gender.
• People who have been diagnosed with one of the following conditions using recognised medical classification systems: Systemic lupus erythematosus (SLE), Sjögren's syndrome, Inflammatory myopathies (muscle inflammation conditions), Systemic sclerosis (scleroderma), Behcet's disease, ANCA-associated vasculitis (a type of blood vessel inflammation), IgG4-related disease, Antiphospholipid syndrome, or Acquired thrombotic thrombocytopenic purpura (a blood clotting disorder).
• People whose condition has not responded adequately to multiple treatments, including high-dose steroids, immunosuppressant medicines, and/or biologic medicines.
• People who have been on a stable dose of steroids (at or below a set level) and/or disease-modifying medicines for at least 4 weeks before starting the trial, with no planned increases in those doses during the study.
• People who are willing to voluntarily participate and sign a consent form.
• People who could become pregnant, or whose partner could become pregnant, who agree to use effective contraception throughout the study (note: certain hormone-based contraceptives such as oral oestrogen or oestrogen vaginal rings are not permitted).
• People with Behcet's disease who are in an active phase of the disease, meaning new or worsening symptoms are present, and who meet at least one specific activity measure — such as involvement of a major organ, a significant increase in mouth or genital ulcers, longstanding ulcer history, frequent monthly ulcers, worsening joint swelling, or worsening skin lesions (confirm with trial site for exact scoring details).
• People with active inflammatory myopathy who score no more than 125 out of 150 on a standardised muscle strength test, and who also meet at least 2 additional activity measures related to patient-reported wellbeing, doctor-assessed disease activity, physical function, elevated muscle enzymes, or overall disease activity scoring (confirm with trial site for exact scoring details).
• People with ANCA-associated vasculitis who meet classification criteria for GPA, MPA, or EGPA, and who have severe vasculitis activity — including specific types of kidney involvement or lung bleeding confirmed by imaging and clinical evidence (confirm with trial site for exact scoring details).
• People with systemic sclerosis who are considered at high risk of serious outcomes, specifically those with widespread skin thickening scoring at or above 16 on a standard scale, confirmed on two separate occasions, and who also have either SSc-related lung disease meeting specific breathing test thresholds, or a history of SSc-related kidney crisis meeting defined blood pressure and organ-involvement criteria (confirm with trial site for exact scoring details).
• People with systemic lupus erythematosus who score 7 or above on a standard disease activity scale before joining, and whose condition has not responded to specified doses of steroids and/or immunosuppressant medicines over defined treatment periods.
• People with antiphospholipid syndrome who test positive for all three relevant antibodies before joining, and who have a confirmed history of blood clots or pregnancy complications.
• People with Sjögren's syndrome who test positive for anti-Ro/SSA antibodies and score 6 or above on a standard disease activity scale.
• People with IgG4-related disease who have confirmed characteristic organ swelling or masses on clinical examination, elevated IgG4 levels in the blood (above 135 mg/dL), and tissue biopsy results showing the specific patterns of immune cell activity and scarring associated with this condition.

Who may not be able to join:

• People who have received rituximab or other monoclonal antibody medicines within approximately the past 1.6 months.
• People who have received high-dose steroids (above a set daily threshold) within the past month.
• People with serious complications such as severe heart failure (classified as NYHA Class III or above), significantly reduced kidney function (creatinine clearance at or below 30 ml/min), or significant liver problems based on blood test results.
• People with other serious, progressive, or uncontrolled conditions affecting the blood, digestive system, hormones, lungs, heart, nerves, or brain — including demyelinating conditions such as multiple sclerosis.
• People with a known allergy or intolerance to IL-2 or any of its ingredients.
• People who have had a serious infection — including hepatitis, pneumonia, bloodstream infection, kidney infection, Epstein-Barr virus, or tuberculosis — or who were hospitalised for an infection, or treated with intravenous antibiotics for an infection, within the 2 months before the first study dose.
• People whose chest imaging within the 3 months before starting the study shows signs of cancer or active abnormalities related to certain infections, including tuberculosis.
• People who are HIV-positive or hepatitis C antibody-positive.
• People with a known or past cancer diagnosis within the last 5 years — with limited exceptions for certain types of skin cancer or cervical conditions that have been fully treated with no signs of return, as assessed within 3 months before the first study dose (confirm with trial site for exact details).
• People with an uncontrolled mental health or emotional condition, or a history of drug or alcohol misuse within the past 3 years, that may prevent completion of the study.
• People who have received, or are expected to receive, any live virus or live bacterial vaccine within 3 months before the first study dose, during the study, or within 4 months after the last study dose; or a BCG (tuberculosis) vaccine within 12 months of screening.
• Women who are pregnant or breastfeeding, or women of childbearing potential who are unwilling to use medically approved contraception during treatment and for 12 months after treatment ends.
• Men whose partner could become pregnant and who are unwilling to use medically approved contraception during treatment and for 12 months after treatment ends.
• People with inflammatory myopathies who have juvenile-onset disease, myositis overlapping with another connective tissue disease, cancer-associated myositis, inclusion body myositis, or any other non-immune-related muscle disease; or who have severe muscle damage scoring 5 cm or above on a standard 10 cm injury scale.
• People with ANCA-associated vasculitis who test positive for anti-GBM antibodies (a marker associated with a different type of kidney and lung condition).

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