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Plaque PsoriasisNCT06488170

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

An observational study of Plaque Psoriasis, run by Almirall, S.A. at 7 sites in Czechia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis
What is being tested?
Tildrakizumab
How many people
42 participants
Where
7 sitesCzechia
Study dates
4 Apr 2024to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Czechia7 sites
  • University Hospital Ostrava

    Ostrava, 708 52

  • Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše

    Pilsen, 301 00

  • University Hospital Kralovske Vinohrady

    Prague, 100 00

  • University Hospital in Motol

    Prague, 150 06

  • General university hospital Prague

    Prague

  • University Hospital Bulovka

    Prague

  • Masarykova hospital Ústí nad Labem

    Ústí nad Labem

Other trials in Czechia

About this study

Official title: 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).

Being tested
Tildrakizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TildrakizumabDrug

    Also called IL-23p19 inhibitor

    As provided in real world clinical practice.

Study groups in NCT06488170
Study groupRoleWhat they receive
TildrakizumabParticipants 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.
Receives: Drug: Tildrakizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 28

Secondary outcomes (13)
  1. 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.

    Measured: Baseline, Week 16 and 28

  2. 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.

    Measured: Baseline, Week 16 and 28

  3. 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.

    Measured: Baseline, Week 16 and 28

  4. 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".

    Measured: Baseline, Week 16 and 28

  5. 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.

    Measured: Baseline, Week 16 and 28

  6. 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]).

    Measured: Baseline, Week 16 and 28

  7. 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).

    Measured: Baseline, Week 16 and 28

  8. 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'.

    Measured: Baseline, Week 16 and 28

  9. Number of Participants with Psoriasis Treatment on Physician's Satisfaction

    Measured: Baseline, Week 28

  10. 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.

    Measured: Baseline, Week 16 and 28

  11. 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.

    Measured: Baseline, Week 16 and 28

  12. 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.

    Measured: Baseline, Week 16 and 28

  13. 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.

    Measured: Baseline, Week 16 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start4 Apr 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488170
Sponsor's protocol ID
POSITIVE LIGHT
Status last verified
Jun 2025
First submitted
28 Jun 2024
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Plaque Psoriasis, run by Almirall, S.A. at 7 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 5-item World Health Organization Wellbeing Index (WHO-5) Score (time frame: Baseline to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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