Psoriatic Arthritis 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:

• People aged 18 to 75 years old
• People who have had a confirmed diagnosis of Psoriatic Arthritis (PsA) for at least 6 months, and whose condition meets a specific set of classification criteria used by doctors (called the CASPAR criteria)
• People whose PsA is currently active, meaning they have at least 3 swollen and at least 3 tender joints (a swollen finger or toe due to PsA counts as a swollen joint)
• People with a Body Mass Index (BMI) of 27 or above (a measure of body weight relative to height)
• People who have at least one affected joint that doctors can access with an ultrasound-guided needle biopsy (a procedure to take a small tissue sample from the joint lining), and who are able to have this biopsy completed before the trial begins
• People who have at least one psoriasis skin patch that is suitable for a skin biopsy (confirm with trial site, as a small number of participants per treatment group may be enrolled without a skin biopsy if no suitable patch is present)
• People who are able and willing to give their signed agreement to take part in the trial
• People who are willing and able to attend and undergo tissue samples taken from joints, fat tissue, and skin (where appropriate) on at least two separate occasions, performed under local anaesthetic

Who may not be able to join:

• People who have previously been treated with tirzepatide or any medication in the GLP-1 receptor agonist class of drugs
• People who have previously been treated with ixekizumab
• People who have previously been treated with both secukinumab AND bimekizumab (prior treatment with only one of these may be acceptable under certain conditions — confirm with trial site)
• People who have previously been treated with rituximab
• People who have stopped responding to, or been unable to tolerate, more than 3 different classes of advanced arthritis or psoriasis medications (such as TNF inhibitors, certain immune-targeting injections, or JAK inhibitors — confirm with trial site for the full list)
• People currently taking older disease-modifying arthritis drugs (such as methotrexate) or apremilast who have not been on a stable dose for at least 8 weeks before the first biopsy visit, or who have not been taking them for at least 12 weeks before that visit
• People who have used steroid medications (by mouth, injection into a joint, or into the muscle or vein) in the 4 weeks before the first biopsy visit, or who plan to use them before the 12-week biopsy visit
• People who have used steroid creams or ointments on the skin within 2 weeks of the first biopsy visit (those willing to stop using topical steroids at least 2 weeks before the biopsy may still be considered — confirm with trial site)
• People who have received a live, weakened, or recombinant vaccine within 1 month before screening, or who plan to receive one before the 12-week visit
• People who have a known allergy or medical reason preventing the use of local anaesthetics such as lidocaine
• People taking blood-thinning or anti-clotting medications that cannot be safely paused, including certain antiplatelet drugs (not aspirin), warfarin, dabigatran, rivaroxaban, apixaban, or heparin
• People who have previously been treated with insulin, with some exceptions for insulin used during pregnancy or briefly during illness or surgery (confirm with trial site)
• People diagnosed with type 1 diabetes, or type 2 diabetes managed with insulin
• People who have experienced severe low blood sugar episodes or who are unaware when their blood sugar drops dangerously low, within the 6 months before screening
• People who have had diabetic ketoacidosis or a hyperosmolar diabetic emergency in the past year
• People with certain diabetes-related eye conditions, including proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy that requires treatment
• People whose body weight has changed by more than 5% (either gained or lost) in the 3 months before screening
• People who have had, or are planning to have, weight-loss surgery such as gastric bypass (with some exceptions for liposuction or tummy tuck performed more than 1 year before screening — confirm with trial site)
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related inherited condition called Multiple Endocrine Neoplasia type 2
• People with a history of inflammatory bowel disease, including Crohn's disease or ulcerative colitis
• People with a known significant problem with how their stomach empties food, or who regularly take medications that affect this process
• People with a history of pancreatitis (inflammation of the pancreas), whether short-term or long-term
• People with significantly reduced kidney function (confirm with trial site regarding specific measurement thresholds)
• People who have been diagnosed with cancer within the past 5 years, with some limited exceptions for certain early-stage skin cancers or cervical changes that have been fully treated (confirm with trial site)
• People with any other condition — such as significant drug or alcohol use, or a psychiatric condition — that, in the trial doctor's opinion, might prevent safe participation
• People with a significant active or unstable history of major depression, thoughts of suicide, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the past 2 years (those with stable, well-managed conditions may be considered — confirm with trial site)
• People who, in the trial doctor's judgement, are actively having thoughts of suicide or are considered at significant risk
• People diagnosed with other types of inflammatory joint conditions, such as rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, gout, or arthritis related to bowel disease
• People with an active infection at the time of screening
• People who have had a serious, opportunistic, long-lasting, or recurring infection within the 3 months before screening, or who develop such an infection before the trial begins
• People with evidence or suspicion of active or latent tuberculosis (TB) that has not been fully treated according to local medical guidelines
• People currently living with HIV
• People with a current active hepatitis B virus infection
• People with a current active hepatitis C virus infection
• People with a history of repeated or ongoing infections that, in the trial doctor's opinion, would make participation unsafe
• People who have had major surgery within 8 weeks before screening, or who have major surgery planned within 12 weeks of the trial start
• People whose condition otherwise contraindicates (makes medically inadvisable) the use of ixekizumab or tirzepatide, the medications used in this trial
• People with type 2 diabetes whose blood sugar has been poorly controlled, as shown by a specific blood test result above a certain level (confirm with trial site for details)
• People whose routine blood test results at screening fall outside acceptable ranges in ways considered clinically significant, including abnormalities in white blood cells, red blood cells, platelets, liver enzymes, or kidney markers (confirm with trial site for specific values; a repeat test within 14 days may be offered in some cases)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Women of childbearing potential who are not willing or able to use a highly effective method of contraception throughout the trial and for a specified period after it ends (confirm with trial site for full details, including guidance on oral contraceptives if tirzepatide is used)
• People who have taken part in another clinical trial involving an experimental treatment within the past 30 days before joining this trial (or longer, depending on how long the previous experimental treatment stays in the body — confirm with trial site)
• People currently enrolled in another clinical trial involving an experimental treatment or medical research that may conflict with this study
• People who are unable or unwilling to give their informed consent
• People who, for any reason in the opinion of the trial doctor or sponsor, may not be safe to include or whose participation may make the trial results harder to interpret
• People with any other medical reason that makes tissue biopsies inadvisable, in the opinion of the trial doctor

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