None listed
Conditions
Brief summary
The purpose of this research project is to determine whether treatment with semaglutide may help maintain control of psoriasis and reduce the risk of relapse after stopping biologic therapy in people with chronic plaque psoriasis (CPP) who are overweight or living with obesity. The study will also examine whether semaglutide improves weight and metabolic health. Participants will receive semaglutide and will be monitored over 12 months following discontinuation of biologic therapy to assess relapse rates, weight change, metabolic health, quality of life and inflmmatory markers in blood and skin. Participation in this study involves the following three phases: Screening, Treatment, and Study Completion (no additional follow-up after 12 months). In the treatment phase, participants will commence once-weekly subcutaneous semaglutide injections beginning at 0.25 mg and gradually increasing to 2.4 mg per week over 16 weeks. During the dose escalation phase, participants will need to attend clinic monthly, then every 8-10 weeks during the maintenance phase. The trial will involve weight, waist circumfrence and blood pressure measurements, blood samples, physical examinations and quality of life questionnaires.
Interventions
In this study, semaglutide will be given upon stopping biologic therapy to see if it helps maintain psoriasis control. Participants who are currently on a biologic for their Chronic Plaque Psoriasis (CPP) will cease their biologic and commence the semaglutide. Some examples of biologics commonly used for CPP are guselkumab and risankizumab. Other Pharmaceutical Benefit Scheme (PBS) approved biologics for CPP are adalimumab, bimekizumab, etanercept, infliximab, ixekizumab, secukinumab, tildrakizu
In this study, semaglutide will be given upon stopping biologic therapy to see if it helps maintain psoriasis control. Participants who are currently on a biologic for their Chronic Plaque Psoriasis (CPP) will cease their biologic and commence the semaglutide. Some examples of biologics commonly used for CPP are guselkumab and risankizumab. Other Pharmaceutical Benefit Scheme (PBS) approved biologics for CPP are adalimumab, bimekizumab, etanercept, infliximab, ixekizumab, secukinumab, tildrakizumab and ustekinumab. The investigational product (IP) in this study is semaglutide is a once-weekly subcutaneous injection approved for type 2 diabetes and weight management. Once enrolled, participants will be trained by a nurse to self-inject the semaglutide and will self-inejct all subsequent doses. Participants will be titrated up on the semaglutide. They will initially be dosed at 0.25mg and escalate according to standard dosing schedule to a target of 2.4 mg weekly over 16 weeks. Participant will be seen monthly during dose escalation and approximately every 8-10 weeks during the maintenance phase. The maintenance phase will last from Week 24 - Week 52. If dose escalation leads to unacceptable adverse effects, dose-escalation intervals will be extended or the maximum tolerated dose used for the remainder of the 52-week study. Adherence to intervention will be monitored by measuring weight and health outcomes. In addition, participants will be asked to return empty kits for IP accountability.
Sponsors
Bayside Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18–75 years with chronic plaque psoriasis. Overweight or obesity (BMI greater than or equal to 27 kg/m²). On biologic therapy for at least 6 months with complete or near-complete response (PASI 90 or 100). Able to provide informed consent and discontinue biologic therapy at baseline.
Exclusion criteria
Other forms of psoriasis (e.g. pustular, guttate). Contraindication or intolerance to GLP-1 receptor agonist therapy. Recent use of GLP-1 receptor agonists or other obesity medications. Severe comorbidities (e.g., recent cardiovascular event, severe renal impairment, active infection). Pregnancy, breastfeeding, or planned pregnancy.
Outcome results
None listed