Phase 4 Uveitis Trial, Not Yet 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:

• Adults aged 18 or older at the time of their screening visit.
• People who are willing and able to understand the study requirements and sign a consent form before any study procedures begin.
• People who have been diagnosed with axial spondyloarthritis (a type of inflammatory spinal condition) by a rheumatologist.
• People whose condition has been classified according to a specific set of international criteria for axial spondyloarthritis (confirm with trial site).
• People who have had at least one episode of acute anterior uveitis (a type of eye inflammation) diagnosed by an eye doctor in the 12 months before the study start date.
• People whose disease is currently active, based on specific symptom scoring tools showing significant pain and disease activity (confirm with trial site).
• People who have tried at least two different anti-inflammatory medications (NSAIDs) at the highest recommended or tolerated doses for a total of at least 4 weeks without enough relief, or who cannot take NSAIDs due to intolerance or medical reasons.
• People who have been on biological medication (bDMARD) for at least 3 consecutive months and/or anti-inflammatory medication (NSAID) for at least 4 weeks before joining, but still have active disease — or who had to stop those treatments due to side effects or toxicity.
• Women of childbearing potential who have a negative pregnancy test at screening and again before the first dose of study medication.
• People who are regularly taking NSAIDs or certain pain medications as part of their treatment and have been on a stable dose for at least 7 days before the study start date, and have not taken stronger opioid pain medications (with some exceptions) in the 7 days before the study start date.
• People taking oral corticosteroids (steroid tablets) who have been on a stable low dose (no more than the equivalent of 10mg prednisone per day) for at least 14 days before the study start date.
• People taking certain conventional disease-modifying medications (such as methotrexate, sulfasalazine, hydroxychloroquine, chloroquine, or leflunomide) who have been on a stable dose within allowed limits for at least 28 days before the study start date (up to two of these medications may be taken together, with one specific combination not permitted — confirm with trial site).
• People currently on biological therapy (bDMARD) who complete an appropriate medication washout period before the study start date, as determined by which medication they are taking.

Who may not be able to join:

• People with an active infection requiring intravenous antibiotics in the 30 days before the study start, or oral antibiotics in the 14 days before the study start, or who have chronic or recurring infections that the investigator considers a safety concern.
• People who have recently tested positive for COVID-19 and have not yet met the required waiting period or symptom resolution criteria before the study start date.
• People with signs or symptoms that could suggest a current COVID-19 infection, known exposure to COVID-19, or high-risk behaviour, who have not yet had a negative test result or been symptom-free for 5 days.
• People who have had shingles (herpes zoster) more than once, or who have had a severe or widespread single episode of shingles or a widespread episode of herpes simplex.
• People with a primary or secondary immune deficiency (a condition that weakens the body's ability to fight infections).
• People with active tuberculosis (TB) or who do not meet the study's TB testing requirements (confirm with trial site).
• People with a chronic hepatitis B infection, or those who test positive for hepatitis B surface antigen at screening.
• People with a chronic hepatitis C infection with detectable virus, or people with confirmed HIV infection.
• Women who are breastfeeding, pregnant, or planning to become pregnant during the study or within 4 weeks after the last dose of study medication.
• People with other chronic inflammatory joint or autoimmune conditions (such as lupus, Sjögren's syndrome, or rheumatoid arthritis), or conditions such as fibromyalgia or chronic fatigue syndrome that have been clearly diagnosed. People with Crohn's disease or ulcerative colitis may still be eligible if those conditions have not been actively symptomatic in the 4 weeks before the study start date.
• People currently taking certain medications known to strongly interact with the study drug (such as ketoconazole, fluconazole, rifampicin, clarithromycin, or St John's Wort).
• People who have previously been treated with upadacitinib (the study drug) or any other JAK-inhibitor or TYK2-inhibitor for axial spondyloarthritis.
• People with a known allergy to any ingredient in upadacitinib tablets.
• People who have received steroid injections (into a vein, muscle, joint, or rectally) in the 4 weeks before the study start, or who have been taking oral steroids at a dose higher than the equivalent of 10mg prednisolone per day in the 4 weeks before the study start.
• People who have taken any other investigational (trial) drug within 30 days or five half-lives of that drug (whichever is longer) before the first dose, or who are currently enrolled in another interventional clinical trial.
• People who have ever had an infected joint replacement that is still in place.
• People with a current or past cancer diagnosis within the last 5 years, with some exceptions for certain skin cancers or cervical changes that were successfully treated.
• People with conditions that may affect how oral medication is absorbed by the body, such as having had part of the stomach removed or certain types of weight-loss surgery (confirm with trial site).
• People who have had major surgery or a significant injury in the 4 weeks before the study start date.
• People with severe uncontrolled conditions affecting the gut, liver, kidneys, lungs, heart, nervous system, or hormonal system.
• People with any history of a heart attack, stroke, coronary stenting, or bypass surgery.
• People with a history of blood clots or a blood disorder that increases the risk of clotting.
• People who have received a live or weakened live vaccine in the 4 weeks before the first dose of study medication, or who are expected to need such a vaccine during treatment or within 4 weeks after the last dose.
• People whose blood test results at screening fall outside the acceptable ranges for red blood cells, white blood cells, platelets, liver function, or kidney function (confirm with trial site for specific values).

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