An observational study in Plaque Psoriasis, sponsored by Almirall, S.A.. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Almirall, S.A. · Observational
This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 782 is above the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Almirall, S.A. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients with moderate-to-severe plaque psoriasis who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor treatment in real-world clinical practice.
Exclusion Criteria:
Patients diagnosed with moderate-to-severe plaque psoriasis who require systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor in real-world clinical practice, following the routine clinical practice on each patient country, will be observed for 24 months.
Drug: Tildrakizumab
As provided in real world clinical practice.
Also known as: IL-23p19 inhibitor
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Time frame: Baseline and Month 24
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 months after baseline visit
Change from Baseline in Physician's Satisfaction Questionnaire Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in FamilyPso Questionnaire Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Dermatology Life Quality Index-Relevant (DLQI-R) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Treatment-related Patient Benefit Index 2.0 (PBI 2.0) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Skin Manifestations Distribution (Patient's Grid/Heat Map)
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Numerical Rating Scale (NRS) Scores for Itch, Pain, Joint Pain and Fatigue
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Change from Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline; 16 and 28 weeks; 12, 18 and 24 months after baseline visit
Number of Patients Compliance to Sociodemographic Characteristics and Clinical Characteristics
Time frame: From Baseline up to 24 months
Number of Patients With Treatment-emergent Adverse Events (TEAE)
Time frame: From Baseline up to 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Almirall, S.A.