Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07443956

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

117 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

Researchers are evaluating how weight loss achieved by tirzepatide or treatment with ixekizumab affects the skin, joint, and fat tissues in adults with Psoriatic Arthritis, Psoriasis, and a body mass index (BMI) of 27 or higher. The study aims to understand molecular changes in these tissues and how they relate to weight loss and disease activity. Participants have Psoriatic Arthritis diagnosed for at least six months and active disease. Participants will be randomly assigned to one of three groups receiving tirzepatide alone, ixekizumab alone, or a combination of both drugs. They will undergo ultrasound-guided synovial biopsies, skin biopsies, skin tape sampling, and fat biopsies at the start and at 12 weeks. Optional additional biopsies can be done at 36 weeks. Blood and urine samples will be collected at several time points up to 52 weeks. Those on tirzepatide who do not achieve minimal disease activity may be offered ixekizumab at specified weeks. During the 52-week study, disease activity will be monitored through examinations and questionnaires. Samples collected at various intervals will be used to assess molecular changes linked to weight loss and immunomodulation. The main measure is molecular changes in tissue biopsies at 12 weeks, with secondary measures including blood molecular changes and comparisons between treatments. Safety and disease activity are closely followed throughout the trial.

CONDITIONS

Brief 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
  • Documented diagnosis of Psoriatic Arthritis for at least 6 months meeting CASPAR criteria
  • Active Psoriatic Arthritis with at least 3 swollen and 3 tender joints
  • Body mass index (BMI) of 27 kg/m2 or higher
  • At least one joint suitable for ultrasound-guided synovial biopsy
  • At least one psoriatic plaque suitable for skin biopsy (exceptions allowed for limited participants)
  • Ability to provide signed informed consent
  • Willingness and ability to undergo synovial, adipose, and skin biopsies under local anesthetic at least twice
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 three classes of advanced therapies
  • Recent use of corticosteroids or unstable doses of DMARDs
  • Recent live or recombinant vaccinations
  • Contraindications to local anesthetics or biopsies
  • Use of certain antiplatelet or anticoagulant therapies that cannot be safely interrupted
  • Previous insulin treatment except short-term or gestational use
  • Type 1 diabetes or insulin-treated type 2 diabetes
  • History of severe hypoglycemia or ketoacidosis
  • Certain diabetic eye conditions requiring treatment
  • Significant recent body weight change
  • Prior or planned bariatric surgery
  • Family or personal history of medullary thyroid carcinoma or MEN syndrome type 2
  • History of inflammatory bowel disease
  • Significant gastric emptying disorders or pancreatitis
  • Severe renal impairment
  • Recent or history of certain cancers
  • Psychiatric disorders with significant instability
  • Other inflammatory arthritis diagnoses
  • Active or recent serious infections
  • Evidence or suspicion of active or latent tuberculosis
  • Current infections with HIV, hepatitis B or C
  • History of recurrent or chronic infections posing risk
  • Recent major surgery
  • Other contraindications to study drugs or biopsies
  • Poorly controlled diabetes indicated by lab results
  • Clinically significant abnormal lab test results
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception
  • Recent participation in other investigational studies
  • Enrollment in incompatible medical research
  • Inability or unwillingness to provide informed consent
  • Any condition compromising safety or study data

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 52 weeks

Participants receive either tirzepatide, ixekizumab, or both drugs. They undergo biopsies and sample collections to evaluate molecular changes associated with weight loss and immunomodulation.

Visits at weeks 0, 4, 12, 24, 36, and 52 for biopsies, blood, urine samples, and clinical assessments

Follow-up

Duration - Up to 52 weeks

Participants are monitored for disease activity and may receive additional biopsies at week 36 if they consent.

Additional visit at week 36 for optional biopsies

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

P

Project Manager

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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Published Research Related To This Trial

Psoriatic arthritis is associated with adverse body composition predictive of greater coronary heart disease and type 2 diabetes propensity - a cross-sectional study.

Lyn D Ferguson, Jennifer Linge, Olof Dahlqvist Leinhard...

https://pubmed.ncbi.nlm.nih.gov/33147607

Discrepancy in Metabolic Syndrome between Psoriatic Arthritis and Rheumatoid Arthritis: a Direct Comparison of Two Cohorts in One Center.

Borui Li, Hong Huang, Juan Zhao...

https://pubmed.ncbi.nlm.nih.gov/36264448

Systematic review and meta-analysis on prevalence of metabolic syndrome in psoriatic arthritis, rheumatoid arthritis and psoriasis.

Aravinthan Loganathan, Narainraj Kamalaraj, Carlos El-Haddad...

https://pubmed.ncbi.nlm.nih.gov/34076348

Comparison of Psoriatic Arthritis and Rheumatoid Arthritis Patients across Body Mass Index Categories in Switzerland.

Enriqueta Vallejo-Yagüe, Theresa Burkard, Burkhard Möller...

https://pubmed.ncbi.nlm.nih.gov/34300360

Comorbidities in Early Psoriatic Arthritis: Data From the Metabolic Disturbances in Psoriatic Arthritis Cohort Study.

Alla Ishchenko, Sofia Pazmino, Barbara Neerinckx...

https://pubmed.ncbi.nlm.nih.gov/37667975