Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis (NCT07443956) | Clinical Trial Compass
RecruitingNot Applicable
Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis
United Kingdom45 participantsStarted 2026-03-09
Plain-language summary
This is a trial to find out how weight loss (achieved by the use of tirzepatide) or ixekizumab treatment affects the characteristics of skin, joint and fat tissues in patients with Psoriatic Arthritis, Psoriasis and obesity/overweight BMI \>=27.
Participants will be allocated either Tirzepatide, Ixekizumab or both. Samples of joint tissue, fat and skin will be taken at the start of the study and week 12. Blood and urine samples will also be taken.
The primary objective will be to assess the changes seen in the joint, fat and skin tissue samples 12 weeks after starting the medications (additional analysis will be done on the optional 36 week samples).
Secondary objectives will be
* To assess the changes seen in blood 4, 12, 36 and 52 weeks after starting the medication.
* To compare the changes seen in tissue and blood between Ixekizumab and Tirzepatide/Weight loss.
* To see how the changes seen in the tissue relate to weight loss.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>= 18 years and \<=75 years
. Have a documented diagnosis of PsA for at least 6 months AND fulfil the CASPAR criteria (Defined as \>=3 points)
. Have active PsA defined as \>=3 swollen and \>=3 tender joints (dactylitis counts as a swollen joint).
. Have a BMI \>= 27 kg/m\^2
. Have at least one affected joint amenable to ultrasound-guided synovial biopsy (and must undergo successful synovial biopsy prior to randomisation)
. Have at least one psoriatic plaque amenable to biopsy (up to a maximum of 5 participants per treatment arm can be recruited without skin biopsy if no suitable lesion
. Capable of giving signed informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of molecular changes in biopsies (skin, synovial and adipose) with weight loss
. Willing and able to participate in the study and undergo synovial, adipose and skin (if appropriate) biopsies (under local anaesthetic) on at least 2 occasions
Exclusion criteria
. Previous treatment with tirzepatide or any GLP-1 receptor agonist.
. Previous treatment with Ixekizumab.
. Previous treatment with BOTH secukinumab AND Bimekizumab. \[note: Previous treatment with one of EITHER secukinumab OR Bimekizumab for PsA/psoriasis is allowed PROVIDED: i) Last dose was \>6months before baseline AND ii) Therapy was not stopped due to an IL-17-related side effect OR due to complete primary lack of response.
. Previous treatment with rituximab.
. Failed \>3 classes of advanced therapies (regardless of given for PsA or psoriasis), including but not limited to:
. If currently receiving conventional DMARDs, or apremilast, must have been treated for at least 12 weeks prior to first biopsy visit and on a stable dose for at least 8 weeks prior to first biopsy visit.
. Use or oral, intra-articular, IM or IV corticosteroids 4 weeks prior to first biopsy visit or anticipated/planned prior to the week 12 biopsy visit.
. Topical steroids within 2 weeks of first biopsy visit (participants on topical corticosteroids at baseline willing to leave these off 2 weeks prior to biopsy will be eligible).