Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Recruiting now · Not applicable

Conditions studied: Psoriatic Arthritis (PsA), Obesity & Overweight

In brief

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.

Key facts

Study ID

NCT07443956

Run by

NHS Greater Glasgow and Clyde

People needed

45

Starts

2026-03-09

Expected to finish

2030-05-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• Prior/Concomitant Therapy:
• 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:
• TNF inhibitors (adalimumab, etanercept, certolizumab, golimumab, and infliximab)
• IL-12/23 inhibitors (ustekinumab)
• IL-23 inhibitors (guselkumab and risankizumab)
• IL-17 Inhibitors (secukinumab or bimekizumab)
• Selective co-stimulation modulators (abatacept)
• Janus Kinase or tyrosine kinase 2 inhibitors (tofacitinib, upadacitinib and deucravacitinib) Note: Prior exposure to phosphodiesterase-4 inhibitors, such as apremilast and conventional synthetic DMARDs, such as methotrexate, are not considered as advanced therapies.
• 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).
• Live, attenuated or recombinant vaccination within 1 month prior to screening visit or planned before the 12 week visit.
• Contraindication to local anaesthetics (lidocaine/similar) used for biopsies
• Antiplatelet or anticoagulant therapy that cannot be safely interrupted:
• Clopidogrel or other antiplatelet therapies (note: aspirin is not an exclusion)
• Vitamin K antagonists (including but not limited to warfarin)
• Direct inhibitors of thrombin (e.g. dabigatran)
• Factor Xa inhibitors (e.g. rivaroxaban, apixaban)
• Heparins (including low-molecular weight heparins (LMWH)
• Previous treatment with insulin (exception: Use of insulin for gestational diabetes or short-term use (less than 14 days) for acute conditions, such as acute illness, hospitalisation or elective surgery).
• Medical Conditions:

Where it is running

• NHS Greater Glasgow and Clyde — Glasgow, Scotland, United Kingdom (enrolling)
• University Hospitals Birmingham NHS Foundation Trust — Birmingham, England, United Kingdom
• University Hospitals Coventry and Warwickshire NHS Trust — Coventry, England, United Kingdom
• The Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, England, United Kingdom

Full record on ClinicalTrials.gov

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