Phase 2 Ankylosing Spondylitis 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:

For healthy volunteers:

• You are a man or woman aged 18 to 55 years old at the time of your screening appointment
• You are willing and able to sign a consent form agreeing to take part in the study
• You are able and willing to follow all the study rules, including any food and drink restrictions (such as avoiding grapefruit juice)
• You and your partner are willing to use contraception as required by the study rules
• You are a non-smoker, or you stopped smoking at least 6 months ago
• Your Body Mass Index (BMI — a measure based on your height and weight) is between 19 and 30

For people with Axial Spondyloarthritis (AxSpA — a type of inflammatory back condition):

• You are a man or woman aged 18 to 65 years old
• You have been diagnosed with Axial Spondyloarthritis and meet specific classification criteria, including testing positive for a gene marker called HLA-B27, AND/OR having signs of active inflammation on an MRI scan or in a blood test (raised CRP of 5.0 mg/L or above)
• You have had symptoms for at least 3 months
• Your symptoms first started before the age of 40
• Your disease activity score (called ASDAS) is 2.1 or above while on your current treatment, showing your condition is not well controlled
• You are currently taking a type of anti-inflammatory painkiller (called an NSAID) at the right dose and for long enough, but it is not working well enough — OR you cannot take NSAIDs because of side effects or other medical reasons
• You have received at most one previous biologic or JAK inhibitor treatment (or up to two in Australia) and stopped it because it did not work or caused side effects
• If you received previous biologic or JAK inhibitor treatments, you have completed a required "washout" period (a break from that medication) before starting the trial: at least 4 weeks or 5 half-lives (whichever is longer) for biologic treatments, or at least 2 weeks for JAK inhibitor treatments

Who may not be able to join:

For healthy volunteers:

• You have any significant medical history, physical findings, or abnormal test results that the investigator considers a concern for your safety in the study
• You have taken part in a study involving a new drug in the last 124 days, or a study with an already-approved drug in the last 93 days
• You have a known infection with HIV, hepatitis B, or hepatitis C, or have lifestyle factors that put you at known risk of these infections

For people with AxSpA:

• You have received more than one biologic or JAK inhibitor treatment (or more than two in Australia), or you are currently taking other disease-modifying medications not permitted by the study, or you have ever taken thalidomide
• Your blood counts are too low, for example low red blood cells, white blood cells, infection-fighting cells (neutrophils or lymphocytes), or platelets (confirm with trial site for exact values)
• Your liver function blood tests are significantly above the normal range (more than 1.5 times the upper limit of normal), except in specific circumstances such as Gilbert's syndrome (confirm with trial site)
• You have been diagnosed with another autoimmune or rheumatic condition, such as lupus, scleroderma, mixed connective tissue disease, or fibromyalgia
• You currently have active or symptomatic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) — though a past history of IBD that is no longer active may be allowed (confirm with trial site)
• You currently have active anterior uveitis (a painful inflammation at the front of the eye)

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