Plaque PsoriasisNCT06030076
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 1 site in Austria.
Trial summary
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Tildrakizumab
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 6 Sep 2023to Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.
Who may be able to join
- Written informed consent.
- >=18 years of age.
- Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
- Switch to tildrakizumab due to:
- primary or secondary treatment failure (PASI >= 3 or ΔPASI < 75 and/or DLQI > 5)
- adverse events, contraindication, intolerance
- patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
- Treatment with tildrakizumab planned in the frame of clinical practice.
Who cannot join
- Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
- >=3 previous biologic treatments in the last 3 years.
- Participation in a clinical trial simultaneous to participation in SW-ATCH.
- Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
- Patient dependent on the Investigator.
- Previous treatment with Tildrakizumab.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Gesundheitszentrum Citypark Graz
Graz, Styria, 8010
About this study
Official title: A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis in Austria and Switzerland
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.
- Conditions
- Plaque Psoriasis
- Being tested
- Tildrakizumab
- Keywords
- Psoriasis, Tildrakizumab, Moderate-to-severe plaque psoriasis, Prospective
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TildrakizumabDrug
Also called Ilumetri®
As provided in real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Tildrakizumab | Participants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks. Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.
Measured: Baseline, Week 28
World Health Organisation Well-Being Index (WHO-5) Score
The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: Baseline up to Week 28
Secondary outcomes (4)
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 4, 16 and 28
Change from Baseline in Physician's Global Assessment (PGA) Score
The PGA is an instrument used in clinical trials to rate the severity of psoriasis. It is a 5-point scale measurement ranging from 0 to 4, where 0- clear, 1- almost clear, 2- mild, 3- moderate and 4- severe; based on degree of plaque thickening, scaling and erythema.
Measured: Baseline, Week 4, 16 and 28
Change from Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.
Measured: Baseline, Week 4, 16 and 28
Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start6 Sep 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030076
- Sponsor's protocol ID
- SW-ATCH
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective Cohort, Multicentre, Real-world Evidence Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis in Austria and Switzerland
- ClinicalTrials.gov ID
- NCT06030076
- Acronym / sponsor ID
- SW-ATCH
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Tildrakizumab, Moderate-to-severe plaque psoriasis, Prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab | – | Drug: TildrakizumabParticipants who have been prescribed tildrakizumab to manage moderate-to-severe plaque psoriasis according to summary of product characteristic (SmPC) in routine clinical practice settings will be observed prospectively for up to 28 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female participants with moderate to severe plaque psoriasis will be observed in this study.
Key inclusion criteria (8 listed)
- Written informed consent.
- >=18 years of age.
- Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
- Switch to tildrakizumab due to:
- Treatment with tildrakizumab planned in the frame of clinical practice.
Key exclusion criteria (6 listed)
- Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
- >=3 previous biologic treatments in the last 3 years.
- Participation in a clinical trial simultaneous to participation in SW-ATCH.
- Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
- Patient dependent on the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TildrakizumabAlso: Ilumetri®As provided in real-world clinical practice. | Drug | Tildrakizumab |
Primary outcome
Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score
Time frame: Baseline, Week 28
TSQM 11-item scale is derived from the TSQM version 1.4, which comprises four domains: global satisfaction, medication effectiveness, convenience, and side effects with scores at each domain ranging from 0 to 100. Higher scores indicating greater satisfaction and lower scores reflecting room for improvement.
World Health Organisation Well-Being Index (WHO-5) Score
Time frame: Baseline up to Week 28
The WHO-5 consists of 5-items that measure current mental well-being. Each item is rated on 6-point Likert scale, ranging from 0 (at no the time) to 5 (all of the time). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
4 secondary outcomes
Change from Baseline in absolute Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline, Week 4, 16 and 28
Change from Baseline in Physician's Global Assessment (PGA) Score
Time frame: Baseline, Week 4, 16 and 28
Change from Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline, Week 4, 16 and 28
Number of Participants with Individual Reasons for Initiating Switch to Tildrakizumab
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Almirall, S.A. at 1 site in Austria.
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 8 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Contact Senior Director Regional Medical Affairs (+43 0 15953960, medicalat@almirall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction Questionnaire for Medication-11 (TSQM-11) Score (time frame: Baseline, Week 28). The study lists 2 primary outcomes in all. 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 29 Jan 2025.