Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

ConditionsPsoriatic Arthritis (PsA)Obesity & Overweight

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Ixekizumab
Drug
anti-IL17A monoclonal antibody
Tirzepatide
Drug
GLP-1 and GIP agonist

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Tirzepatide groupActive comparator 1 intervention

Group B: Ixekizumab groupActive comparator 1 intervention

Group C: Combined tirzepatide and ixekizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

Correlation of molecular changes in biopsies (skin, synovial and adipose) with weight loss

Percentage change in weight (in kg) from baseline will be correlated with changes in molecular markers in tissues (synovium, skin and adipose). This is an experimental medicine (and not efficacy) study that will utilise a range of advanced spatial and other tissue omics to measure molecular markers in these tissues at baseline and 12 weeks. It is not possible or appropriate to specify a single biomarker or measure for this.

Time frame

12 weeks

Secondary outcomes

Correlation of changes in molecular signatures in the peripheral blood with weight loss.

Percentage change in weight (in kg) from baseline will be correlated with changes in molecular markers in peripheral blood. This is an experimental medicine (and not efficacy) study that will utilise a range of advanced techniques to measure molecular markers in blood at baseline and 12 weeks. It is not possible or appropriate to specify a single biomarker or measure for this.

Time frame

12 weeks

Comparison of molecular changes in biopsies (skin, synovial and adipose) and in the peripheral blood with weight loss versus those with immunomodulation by IL-17A inhibition.

Comparison of molecular changes in biopsies (skin, synovial and adipose) and in the peripheral blood with % change in weight (in kg) from baseline will be compared between the three treatment arms. A range of advanced analyses will be used to evaluate the correlation of molecular (immune) changes in tissues (synovium, skin and adipose) and peripheral blood with weight loss alone, compared with changes seen with immunomodulation alone or immunomodulation in combination with weight loss. It is not possible or appropriate to specify a single biomarker.

Time frame

12 weeks

Other outcomes

Correlation of changes in molecular signatures in the peripheral blood with weight loss.

Percentage change in weight (in kg) from baseline will be correlated with changes in molecular markers in peripheral blood. This is an experimental medicine (and not efficacy) study that will utilise a range of advanced techniques to measure molecular markers in blood. It is not possible or appropriate to specify a single biomarker or measure for this.

Time frame

Weeks 4, 24, 36 and 52.

Correlation of changes in weight with PsA disease activity measures.

Percentage change in weight (in kg) from baseline will be correlated with validated PsA disease activity measures (66/68 joint counts, MDA, DAPSA, CRP, PASI, PROs).

Time frame

Weeks 4, 12, 24, 36 and 52.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov

Apply now