None listed
Conditions
Brief summary
Plaque psoriasis is a multifaceted immunological condition primarily resulting from a dysfunctional immune response with T-cells at the center of immunogenesis. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with moderate to severe plaque psoriasis and your treating physician has prescribed you Tildrakizumab. Your treating physician will have prescribed two loading doses of Tildrakizumab 4 weeks apart. Study details: This is an observational study that uses high quality photography and investigator assessments to determine changes to plaque psoriasis over a period of 64 weeks (Study visits will be conducted at week 0,4,8,16,28,40,52 and 64.). The aim of the study is to evaluate the efficacy of Tildrakizumab in the resolution/treatment of psoriasis.
Interventions
Efficacy of Tildrakizumab in adults with moderate-to-severe plaque psoriasis will be evaluated through photographic analysis from baseline to week 64.
Patients will be receiving Tildrakizumab every 12 weeks following two loading doses 4 weeks apart, by the decision of the treating physician (prior to offering this trial). Week 0 will coincide with the first loading dose, and the second will occur at Week 4, both in clinic. Subsequent observation sessions will occur immediately following admini
Efficacy of Tildrakizumab in adults with moderate-to-severe plaque psoriasis will be evaluated through photographic analysis from baseline to week 64. Patients will be receiving Tildrakizumab every 12 weeks following two loading doses 4 weeks apart, by the decision of the treating physician (prior to offering this trial). Week 0 will coincide with the first loading dose, and the second will occur at Week 4, both in clinic. Subsequent observation sessions will occur immediately following administration of Tildrakizumab as scheduled. Observational study visits will occur at scheduled visited at Week 0,4,8,16,28,40,52 and 64 with each visit requiring time to review any adverse events, concomitant medication collection, vital signs, targeted physical examination, quality of life questionnaires and full body photography administered by treating dermatologist. Each scheduled visit should take no longer than approximately 120 minutes. Patients that chose to not enrol or are ineligible are required to be PBS-approved in order to receive Tildrakizumab treatment.
Sponsors
Samson Clinical Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) Adults (aged 18 years and above) who are eligible for systemic therapy or phototherapy. ii) Moderate to severe plaque psoriasis with a PASI equal 15 and BSA equal 10% iii) Minimum diagnosis of 6 months prior to Baseline iv) Active plaque psoriasis present for at least 6 months from initial diagnosis v) Failed to achieve an adequate response based on PASI assessment, contraindicated or intolerant to at least 3 of 4 systemic treatments for plaque psoriasis.
Exclusion criteria
i) Previous/current treatment with IL23. ii) Previous exposure to other biologics agents iii) Diagnosis of other forms of psoriasis other than plaque psoriasis iv) Pregnant or lactating women (Female participants who are pregnant, planning a pregnancy or nursing a child or not on an acceptable and highly effective birth control method)
Outcome results
None listed