Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNHS Greater Glasgow and Clyde
About this trial
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.
Eligibility criteria
Qualifiers
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/m²
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ixekizumab
- Tirzepatide
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
NHS Greater Glasgow and Clyde
Lead sponsor
University of Glasgow
Collaborator
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov