Phase 3 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 who have read and voluntarily signed the consent form for this study
• People aged 18 to 75 years old (inclusive), of any gender
• People who have been diagnosed with Behçet's disease using the ICBD-2013 diagnostic criteria
• People who have at least 2 mouth ulcers at their first screening visit, and either at least 2 mouth ulcers at the randomisation visit (if that visit is 14–56 days after screening) or at least 3 mouth ulcers at the randomisation visit (if that visit is 0–13 days after screening)
• People whose doctor has determined that their mouth ulcers are not suitable for, or cannot be adequately controlled by, treatments applied directly to the mouth, meaning a whole-body (systemic) treatment is appropriate
• People who are able and willing to use effective contraception throughout the study and for 3 months after the last study dose — this applies to women who could become pregnant and to men who have not had a vasectomy; accepted methods include vasectomy, abstinence, intrauterine devices (IUDs), hormonal contraception (pills, patches, rings, injections, or implants), and barrier methods (diaphragms, cervical caps, sponges, or condoms)
• People who are able to attend all follow-up visits and follow the study requirements

Who may not be able to join:

• People who have active Behçet's disease affecting major organs such as the lungs, blood vessels, digestive tract, or brain and nervous system, where immune-suppressing treatment is required; this also includes people who had a bowel perforation, active bleeding, or blockage within 3 months before randomisation
• People who have had a significant heart condition (such as unstable heart disease, severe heart failure, or a heart attack) or a significant abnormal heart tracing (ECG) in the 6 months before screening, if the doctor believes this could affect safety or study results
• People who have recently used certain immune-modifying medicines before randomisation, including: colchicine within 7 days; azathioprine, mycophenolate, baricitinib, or tofacitinib within 10 days; cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone within 4 weeks; or certain biologic medicines within timeframes ranging from 4 to 26 weeks depending on the specific medicine
• People who have recently received corticosteroid injections into a joint or taken systemic (whole-body) corticosteroids within a specified period before randomisation (confirm with trial site for exact timing); note that steroid eye drops are allowed for people with eye symptoms, except within 24 hours before a trial visit
• People who have used certain Chinese herbal or patent medicines with immune-modifying effects within 2 weeks before randomisation, or any Chinese patent medicines or herbal preparations that could affect the study results or that contain specific compounds such as sinomenine, total glucoside of paeony, or tripterygium wilfordii
• People whose blood test results fall outside acceptable ranges, including: low haemoglobin (below 85 g/L), abnormal white blood cell counts (below 3.0 or above 14 ×10⁹/L), low platelet count (below 100 ×10⁹/L), raised creatinine indicating reduced kidney function, raised bilirubin, or raised liver enzyme levels (AST and ALT both at or above 1.5 times the upper limit of normal)
• People who have taken strong inducers of a liver enzyme called cytochrome P450 (such as rifampicin, phenobarbital, carbamazepine, or phenytoin sodium) within 4 weeks before randomisation
• People who have another autoimmune or chronic immune-related inflammatory disease, such as rheumatoid arthritis, lupus, dermatomyositis, multiple sclerosis, Sjögren's syndrome, or inflammatory bowel disease
• People who have a currently active or repeatedly recurring infection (including but not limited to tuberculosis, hepatitis B, hepatitis C, shingles, or certain fungal infections), or who tested positive for hepatitis B surface antigen or hepatitis C antibody, or who had an active mycobacterial infection (including tuberculosis) within the past 3 years unless fully cleared for at least 3 years with documented proof
• People who have clinically significant abnormalities on a chest X-ray or CT scan that the doctor considers a safety concern
• People who have had an organ transplant or have an immune deficiency condition
• People who test positive for HIV or syphilis antibodies
• People who currently have cancer or have had any cancer within the past 5 years, with the exception of certain treated skin cancers or cervical carcinoma in situ with no sign of return in the past 12 months
• People who have taken any other investigational (trial) medicine within 4 weeks before randomisation, or within 5 half-lives of that medicine, whichever period is longer; people who participated in the study known as HM005BD2S01 are also not eligible
• People who are known to be allergic to the study drug or any of its ingredients, or who have a history of significant allergic reactions
• People with a history of alcohol or drug abuse or dependence, or a psychiatric disorder
• People who have conditions that may affect how oral (swallowed) medication is absorbed, such as having had most of the stomach surgically removed, significant diabetic gut disease, or certain types of weight-loss (bariatric) surgery such as gastric bypass (gastric banding, which simply separates the stomach into chambers, is not excluded)
• People who have previously been treated with apremilast
• People who are currently pregnant or breastfeeding
• People who have another serious, progressive, or uncontrolled medical condition that the doctor believes could put them at risk or affect the reliability of the study results

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