Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07443956

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Led by NHS Greater Glasgow and Clyde · Updated on 2026-05-04

45

Participants Needed

4

Research Sites

216 weeks

Total Duration

On this page

Sponsors

N

NHS Greater Glasgow and Clyde

Lead Sponsor

U

University of Glasgow

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Diagnosed with Psoriatic Arthritis for at least 6 months and meet CASPAR criteria (3 or more points)
  • Active Psoriatic Arthritis with 3 or more swollen and 3 or more tender joints (dactylitis counts as swollen joint)
  • Body mass index (BMI) of 27 kg/m2 or higher
  • At least one joint suitable for ultrasound-guided synovial biopsy
  • At least one psoriatic skin plaque suitable for biopsy (exceptions apply for limited cases)
  • Able to provide signed informed consent
  • Willing and able to undergo synovial, adipose, and skin biopsies at least twice under local anesthesia
Not Eligible

You will not qualify if you...

  • Previous treatment with tirzepatide or any GLP-1 receptor agonist
  • Previous treatment with ixekizumab
  • Previous treatment with both secukinumab and bimekizumab
  • Previous treatment with rituximab
  • Failure of more than 3 classes of advanced therapies for Psoriatic Arthritis or psoriasis
  • Use of corticosteroids within 4 weeks prior to first biopsy or planned before week 12 biopsy
  • Recent live, attenuated, or recombinant vaccination within 1 month prior to screening
  • Contraindication to local anesthetics used for biopsies
  • Use of certain antiplatelet or anticoagulant therapies that cannot be interrupted
  • Previous insulin treatment except short-term or gestational diabetes use
  • Diagnosis of type 1 diabetes or insulin-treated type 2 diabetes
  • Recent history of severe hypoglycemia or ketoacidosis
  • Certain diabetic eye diseases requiring treatment
  • Significant weight change (>5%) within 3 months prior to screening
  • Prior or planned bariatric surgery (excluding certain cosmetic surgeries over 1 year ago)
  • Family or personal history of medullary thyroid carcinoma or MEN syndrome type 2
  • History of inflammatory bowel disease
  • Known significant gastric emptying problems or chronic pancreatitis
  • Renal impairment with GFR ≤30 ml/min/1.73m2
  • Recent or history of malignant disease within 5 years except certain skin or cervical cancers
  • History of drug, alcohol abuse or psychiatric disorders affecting study participation
  • Recent major surgery or planned surgery within study period
  • Active or recent serious infections
  • Active or untreated latent tuberculosis
  • Current HIV, hepatitis B, or hepatitis C infection
  • Other inflammatory arthritis diagnoses
  • Pregnancy, breastfeeding, or not using effective contraception
  • Participation in another investigational study within 30 days
  • Unable or unwilling to provide informed consent
  • Any contraindication to biopsies or study drugs as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom, B12 2GW

Not Yet Recruiting

2

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, England, United Kingdom, CV2 2DX

Not Yet Recruiting

3

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, United Kingdom, NE7 7DN

Not Yet Recruiting

4

NHS Greater Glasgow and Clyde

Glasgow, Scotland, United Kingdom, G12 0XH

Actively Recruiting

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Research Team

S

Stefan Siebert, MBBCh, FRCP, PhD

CONTACT

P

Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis | DecenTrialz