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

NCT06488170 | Active Not Recruiting

• 1 other identifier: POSITIVE LIGHT
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change From Baseline in Dermatology Life Quality Index (DLQI) Score

  Baseline, Week 16 and 28

• Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score

  Baseline, Week 16 and 28

• Change from Baseline in Relative PASI Score

  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)

  Baseline, Week 16 and 28

• Number of Participants Achieving Scalp Specific Physician's Global Assessment (PGA) Score

  Baseline, Week 16 and 28

Study Arms (1)

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

Interventions

Tildrakizumab DRUG

As provided in real world clinical practice.

Also known as: IL-23p19 inhibitor

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Written informed consent.

You may not qualify if:

• 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.
• Participant dependent on the investigator, e.g. as employee

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (7)

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše

Pilsen, 301 00, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

University Hospital in Motol

Prague, 150 06, Czechia

Location

General university hospital Prague

Prague, Czechia

Location

University Hospital Bulovka

Prague, Czechia

Location

Masarykova hospital Ústí nad Labem

Ústí nad Labem, Czechia

Location

MeSH Terms

Interventions

tildrakizumab

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: April 4, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7)