A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting

Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

Study Overview

• Status: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Tildrakizumab

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Czechia
  • Ostrava, Czechia, 708 52
    • University Hospital Ostrava
  • Pilsen, Czechia, 301 00
    • Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše
  • Prague, Czechia, 100 00
    • University Hospital Královské Vinohrady
  • Praha, Czechia
    • General University Hospital Prague
  • Praha, Czechia, 150 06
    • University Hospital in Motol
  • Praha, Czechia
    • University Hospital Bulovka
  • Ústí Nad Labem, Czechia
    • Masarykova hospital Ústí nad Labem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of participants with diagnosis of moderate-to-severe plaque psoriasis in accordance with the SmPC.

Description

Inclusion Criteria:

• Participant with diagnosis of moderate or severe chronic plaque PSO documented in the medical chart.
• Participant who needs systemic biologic therapy and qualifies for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-Il-23p19 selected therapy before including the patient in the study.
• Participant aged greater than or equal to (>=) 18 years at Inclusion.
• Written informed consent.

Exclusion Criteria:

• Participant unable or unwilling to comply with the requirements of the study.
• Participant who should not participate in the study for any reason at the discretion of the treating physician.
• Participants participating in a simultaneous clinical trial.
• Any contraindication against the use of Tildrakizumab according to the SmPC.
• Exposure to >= 3 biologics prior to inclusion.
• Participant dependent on the investigator, e.g. as employee

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tildrakizumab; Participants who received Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the SmPC will be observed for Week 28.	Drug: Tildrakizumab; As provided in real world clinical practice.; Other Names: IL-23p19 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score	The WHO-5 is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.	Baseline to Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Dermatology Life Quality Index (DLQI) Score	DLQI is a dermatology-specific instrument used to measure the impact of skin diseases on patients' quality of life. Which assessed disease impact, monitor treatment effectiveness, guide clinical decision-making. Interpretation of Scores: 0-1: No effect on patient's life 2-5: Small effect on patient's life 6-10: Moderate effect on patient's life 11-20: Very large effect on patient's life 21-30: Extremely large effect on patient's life.	Baseline, Week 16 and 28
Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score	The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.	Baseline, Week 16 and 28
Change from Baseline in Relative PASI Score	The PASI is a measure of psoriasis and psoriatic arthritis severity that will be assessed at baseline and all follow-up visits for participants with psoriasis or psoriatic arthritis. This common clinical measure selects a representative area of psoriasis for each body region. The intensity of redness, thickness, and scaling of the psoriasis is assessed by the clinician. PASI scores range from 0 to 72, with higher scores indicating worse symptoms.	Baseline, Week 16 and 28
Change from Baseline in Patient´s Assessment of Itch, Pain and Joint Pain as Measured by Numerical Rating Scale (NRS)	NRS is the simplest and most commonly used scales to indicate the degree of pain, itch, and discomfort. The numerical scale is most commonly 0 to 10, with 0 being "no pain or Itch or discomfort" and 10 being "the worst imaginable pain or Itch or discomfort".	Baseline, Week 16 and 28
Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score	Scalp PGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.	Baseline, Week 16 and 28
Number of Participants Achieving Nail Specific PGA Score	The nail specific PGA is used to evaluate the current status of a participant's nail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]).	Baseline, Week 16 and 28
Number of Participants Achieving Palmoplantar PGA Score	The PGA is a widely used outcome measure that relies on physician visual assessment of disease severity. The PGA determines psoriasis severity at a single point in time, without taking the baseline disease condition into clear (0), almost clear (1), mild (2), moderate (3), severe (4).	Baseline, Week 16 and 28
Number of Participants with Psoriasis (PSO) on Family and Partners by Family PSO Questionnaire	PSO is a self-administered questionnaire designed to address impact of PSO on family and partners by Family PSO questionnaire. Family PSO is a self-administrated questionnaire to assess the burden on partners of patients with psoriasis. The questionnaire has 15 items divided into five factors: (1) perceived strain by social reactions to the partner's psoriasis; (2) strain caused by cleaning; (3) acute emotional strain attributed directly to the psoriasis; (4) restrictions of social life; and (5) general emotional strain. The items are scaled in a 5-point Likert format: 0='not true', 1='somewhat true', 2='moderately true', 3='quite true', 4='very true', with the supplementary option 'does not apply to me'.	Baseline, Week 16 and 28
Number of Participants with Psoriasis Treatment on Physician's Satisfaction		Baseline, Week 28
Hospital Anxiety and Depression Scales (HADS) Questionnaire	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score between 0 and 7 is 'normal', between 8 and 10 shows "light" level, between 11 and 14 "moderate" level, and between 15 and 21 "severe" level of anxiety/depression.	Baseline, Week 16 and 28
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	FACIT-F is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.	Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and HADS	To determine the correlation between the aforementioned parameters, in particular WHO-5 and HADS. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible.	Baseline, Week 16 and 28
Correlations Between the Aforementioned Parameters, in Particular WHO-5 and FACIT-F	To determine the correlation between the aforementioned parameters, in particular WHO-5 and FACIT-F. Correlations between parameters are tested by the non-parametric Spearman test. In case of significant correlations, and if the nature of the data allows it, the conduct of more advanced regression analyses is permissible.	Baseline, Week 16 and 28

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Investigators: Study Director: Study Director, Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Interleukin-23
• Other Study ID Numbers: POSITIVE LIGHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No