Phase 2 Uveitis Trial, Not Yet 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:

• You are 18 years old or older
• You are willing and able to sign a consent form before any study procedures begin
• You have been diagnosed with Behçet's disease (based on recognised international criteria) or have a history of mouth/genital ulcers (aphthosis)
• You have been diagnosed with a non-infectious type of eye inflammation (uveitis) affecting the middle or back part of at least one eye, confirmed using standard international diagnostic criteria
• Your eye inflammation is considered sight-threatening, meaning your vision has dropped significantly, and/or you have swelling or inflammation at the back of your eye (such as macular oedema or inflammation of the blood vessels in the retina)
• You have had a chest X-ray or CT scan within the past 12 weeks showing no signs of active tuberculosis (TB), active infection, or cancer
• If you are a woman who could become pregnant, you have had a negative pregnancy test before joining the study
• If you or your partner could become pregnant, you are willing to use highly effective contraception during the study and for a period after stopping treatment (3 months after one study drug and 5 months after the other) — acceptable methods are listed in detail and include various hormonal contraceptives, coils, sterilisation, vasectomised partner, or consistent abstinence; for men, a condom, vasectomy, or consistent abstinence is acceptable
• If you have tested positive for latent (inactive) TB in a blood test within the past 6 months, you may still be eligible if your chest X-ray shows no signs of active TB and you have no TB symptoms — however, you must agree to start a course of preventative TB treatment no later than the time you join the study
• You are covered by a social security or health insurance system (confirm with trial site if unsure whether your coverage qualifies)

Who may not be able to join:

• Your uveitis is caused by an infection, or has a cause other than Behçet's disease
• You have active TB, a history of untreated TB, or a history of serious infections
• You have tested positive for HIV, hepatitis B, or hepatitis C within the past month
• You have had a cancer diagnosis within the past 5 years (with the exception of certain skin cancers that have been fully treated, or non-spreading cervical cancer in situ)
• You have a history of severe allergic reactions (including life-threatening reactions) to medications similar to those used in this trial
• You have a history of multiple sclerosis or any condition involving damage to the protective covering of nerves (demyelinating disorder)
• You have a known allergy or sensitivity to the study drugs or any of their ingredients
• You currently have an active or suspected infection in your eye
• You currently have an active or suspected infection anywhere else in your body
• You have a history of intestinal ulcers or a condition called diverticulitis (inflammation of pouches in the bowel)
• You have a condition called porphyria (a rare disorder affecting the blood or nervous system)
• Your recent blood test results show that your white blood cell count, platelet count, or liver enzyme levels are outside acceptable ranges (confirm specific values with trial site)
• You have received certain immune-suppressing medications (anti-TNF drugs or tocilizumab) within the past month
• You are currently taking azathioprine, mycophenolate mofetil, or methotrexate — these must be stopped before receiving the first dose of the study drug (confirm timing with trial site)
• You have moderate to severe heart failure (classified as Stage III or IV by standard medical criteria)
• You have severe kidney disease or severe liver disease
• You have received a live vaccine within the 4 weeks before joining the study
• You are currently pregnant or breastfeeding

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