Genital PsoriasisNCT06029257
A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)
An observational study of Genital Psoriasis, run by Almirall, S.A. at 1 site in Austria.
Trial summary
The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Genital Psoriasis
- What is being tested?
- Tildrakizumab
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- 14 Nov 2023to Mar 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female psoriasis participants with genital symptoms will be observed in this study.
Who may be able to join
- Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (>=) 3.
- Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
- Age 18 - 99 years.
- Informed consent in writing in accordance with applicable country regulations
- Patient must have plaque psoriasis affecting a body surface area (BSA) >= 1% in a non-genital area at baseline.
- Patient willing and able to fill out study questionnaires.
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.
- Patient exposed to any experimental treatment in the past 3 months prior to baseline.
- 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, including but not restricted to employees of the study site.
- 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
Medizinische Universität Graz
Graz, Styria, 8020
About this study
Official title: Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic
The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.
- Conditions
- Genital Psoriasis
- Being tested
- Tildrakizumab
- Keywords
- Psoriasis, Plaque psoriasis, Skin Diseases, Tildrakizumab
- Medical subject headings
- Psoriasis, Skin Diseases
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 in the treatment of plaque psoriasis with a manifestation in the genital area according to SmPC in routine clinical practice settings will be observed prospectively for up to 52 weeks. Receives: Drug: Tildrakizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)
The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.
Measured: Baseline up to Week 52
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved.
Measured: Baseline up to Week 52
Secondary outcomes (7)
Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score
The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable. Each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).
Measured: Baseline, Week 4, 16, 28 and 52
Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region
Genital region is defined as the labia majora (outer lip), labia minora (inner lip), and perineum (area between vagina and anus) for females; penis, scrotum, and perineum (area between the penis and anus) for males. 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 4, 16, 28 and 52
Change From Baseline in the Dermatological Life Quality Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired.
Measured: Baseline, Week 4, 16, 28 and 52
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
The TSQM-9 is a psychometrically robust and validated instrument to assess participants satisfaction with the treatment they are receiving. It is a self-administered questionnaire that measures participants drug therapy satisfaction considering the last two or three weeks or since the last time the participant took the medication. It consists of 9 items distributed in 3 domains: effectiveness, convenience, and global satisfaction, with scores at each domain ranging from 0 to 100. with higher score indicating higher treatment satisfaction.
Measured: At Week 28 and 52
Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score
The GenPs-SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. 2 Items assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.
Measured: Baseline, Week 28 and 52
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, 28 and 52
Change From Baseline in World Health Organisation - 5 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, Week 28 and 52
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 start14 Nov 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital 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
- 110 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
- NCT06029257
- Sponsor's protocol ID
- CZATCH-2023
- 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
- Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic
- ClinicalTrials.gov ID
- NCT06029257
- Acronym / sponsor ID
- CZATCH-2023
- Conditions
- Genital Psoriasis
- Keywords
- Psoriasis, Plaque psoriasis, Skin Diseases, Tildrakizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (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 check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tildrakizumab | – | Drug: TildrakizumabParticipants who have been prescribed tildrakizumab in the treatment of plaque psoriasis with a manifestation in the genital area according to SmPC in routine clinical practice settings will be observed prospectively for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female psoriasis participants with genital symptoms will be observed in this study.
Key inclusion criteria (6 listed)
- Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (>=) 3.
- Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
- Age 18 - 99 years.
- Informed consent in writing in accordance with applicable country regulations
- Patient must have plaque psoriasis affecting a body surface area (BSA) >= 1% in a non-genital area at baseline.
Key exclusion criteria (5 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.
- Patient exposed to any experimental treatment in the past 3 months prior to baseline.
- 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, including but not restricted to employees of the study site.
- Previous treatment with Tildrakizumab.
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
Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)
Time frame: Baseline up to Week 52
The sPGA-G is a 5-point score ranging from 0 to 4, with a larger score indicating greater severity, based on the physician's assessment of the average thickness, erythema, and scaling of psoriatic genital lesions.
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
Time frame: Baseline up to Week 52
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved.
7 secondary outcomes
Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score
Time frame: Baseline, Week 4, 16, 28 and 52
Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region
Time frame: Baseline, Week 4, 16, 28 and 52
Change From Baseline in the Dermatological Life Quality Index (DLQI) Score
Time frame: Baseline, Week 4, 16, 28 and 52
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
Time frame: At Week 28 and 52
Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score
Time frame: Baseline, Week 28 and 52
Change from Baseline in Physician's Global Assessment (PGA) Score
Time frame: Baseline, Week 4, 16, 28 and 52
Change From Baseline in World Health Organisation - 5 Well-Being Index (WHO-5) Score
Time frame: Baseline, Week 28 and 52
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 Genital 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 6 inclusion and 5 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?
Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1) (time frame: Baseline up to Week 52). 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.