Phase 1 Uveitis 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:

• People aged 18 to 75 who are willing and able to sign a consent form and follow the study requirements (people joining the Bullous Pemphigoid group may be up to age 85, provided they meet a minimum level of physical functioning)
• Women who could become pregnant must agree to either avoid heterosexual intercourse or use highly effective contraception during the study; men must agree to avoid heterosexual intercourse or use contraception, and must not donate sperm
• Antiphospholipid Syndrome (APS) group: People with an established primary APS diagnosis, confirmed by at least one relevant blood test result (positive lupus anticoagulant, anticardiolipin antibodies, or anti-beta-2 glycoprotein-1 antibodies) and at least one clinical feature (specific skin ulcers or kidney disease related to APS)
• Bullous Pemphigoid (BP) group: People diagnosed with BP confirmed by specific skin and laboratory tests, with a disease severity score of 20 or higher, a weekly average itch score of 4 or higher, and who agree to allow photographs of their blisters
• Behçet's Syndrome (BS) group: People diagnosed with BS who have had mouth ulcers at least 3 times in the past year, at least 2 mouth ulcers in the 4 weeks before the screening visit and again at the start of the study, have previously tried at least one non-biologic treatment for BS, and whose ulcers cannot be adequately controlled with topical treatments alone
• Dermatomyositis (DM) group: People with a confirmed or probable DM diagnosis who have not responded adequately to, or cannot tolerate, standard DM treatments, and who meet specific muscle strength and disease activity score thresholds
• Immune-Mediated Necrotising Myopathy (IMNM) group: People clinically diagnosed with a specific type of IMNM (anti-HMGCR or anti-SRP), with significantly elevated muscle enzyme (creatine kinase) levels above 1,000 U/L, who have not responded adequately to or cannot tolerate standard treatments, and who meet a specific muscle strength threshold
• Immune Thrombocytopenia (ITP) group: People with a confirmed persistent or chronic ITP diagnosis, with a platelet count at or below 30 × 10⁹/L on two separate occasions, who have not had a sustained adequate response to a thrombopoietin receptor agonist and at least one other ITP treatment, and who have previously shown some response to at least one prior treatment

Who may not be able to join:

• People who have previously had a severe allergic reaction to a biologic medicine
• People with an active infection currently requiring antiviral, antibiotic, or antifungal treatment
• People who have planned surgery during the study period
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with a serious medical condition or abnormal laboratory results that the trial site considers unsafe for participation
• People with a clinically significant abnormal heart tracing (ECG)
• People with a history of illicit drug or alcohol misuse
• People with a diagnosed autoimmune disease other than the condition they are enrolling for (an exception may apply for people in the DM or IMNM groups who also have Sjögren's syndrome — confirm with trial site)
• People who test positive for hepatitis B, hepatitis C, or HIV
• People with evidence of a current active tuberculosis infection
• People with a history of cancer within the past 5 years
• People who have received another investigational (trial) treatment within 28 days or within 5 half-lives of that treatment, whichever is longer
• People who have ever been treated with an anti-C1s antibody (a specific type of complement-targeting medicine)
• People who have used other complement-inhibiting medicines within the past 3 months
• People receiving any other treatments classified as prohibited by the trial
• People with significantly elevated liver function test results (raised ALT or AST combined with raised bilirubin above specified thresholds)
• APS group only: People whose APS is associated with another systemic autoimmune disease; people who had an acute blood clot within 30 days before screening; people with clot-related APS who are not receiving any anticoagulation treatment; or people on prohibited medications
• BP group only: People who have recently started or increased a dose of corticosteroid (within 2 weeks); people currently taking a medication known to cause or worsen BP (unless the dose has been stable); people who have recently started a topical calcineurin inhibitor or topical PDE4 inhibitor (within 7 days); or people on prohibited medications
• BS group only: People with active serious organ involvement from BS affecting the eyes, lungs, blood vessels, digestive system, or central nervous system; people with a history of blood clots in the past year; or people on prohibited medications
• DM group only: People who showed meaningful improvement between screening and the study start; people with certain other overlapping muscle or connective tissue conditions; people with cancer-associated muscle disease; people with significant permanent muscle damage; people with a history of severe lung disease flares or severe respiratory muscle weakness; people with severe difficulty swallowing due to muscle weakness; or people on prohibited medications
• IMNM group only: People who showed meaningful improvement between screening and the study start; people with certain other overlapping muscle or connective tissue conditions; people with cancer-associated muscle disease; people with significant permanent muscle damage; people with a history of severe lung disease flares or severe respiratory muscle weakness; people with severe difficulty swallowing due to muscle weakness; or people on prohibited medications
• ITP group only: People with secondary ITP (ITP caused by another condition); people with a history of myelodysplastic syndrome or autoimmune haemolytic anaemia; people with a history of blood clots in the past 12 months; people who have had a major bleeding episode within the past 4 weeks; people on prohibited medications; or people whose screening blood tests show haemoglobin below 10 g/dL or a thyroid-stimulating hormone level at or above 10 μIU/mL

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