Clinical trial NCT06029257: A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)
Official title: Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genital Psoriasis
Keywords: Psoriasis
Plaque psoriasis
Skin Diseases
Tildrakizumab
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female psoriasis participants with genital symptoms will be observed in this study.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of "Clear" (0) or "Almost Clear" (1)
timeFrame: Baseline up to Week 52
measure: Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Score
timeFrame: Baseline, Week 4, 16, 28 and 52
measure: Change From Baseline in Pain, Itch, and Discomfort on Numerical Rating Scales (NRS) for the Genital Region
timeFrame: Baseline, Week 4, 16, 28 and 52
measure: Change From Baseline in the Dermatological Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 4, 16, 28 and 52
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Score
timeFrame: At Week 28 and 52
measure: Change From Baseline in Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Score
timeFrame: Baseline, Week 28 and 52
measure: Change from Baseline in Physician's Global Assessment (PGA) Score
timeFrame: Baseline, Week 4, 16, 28 and 52
measure: Change From Baseline in World Health Organisation - 5 Well-Being Index (WHO-5) Score
timeFrame: Baseline, Week 28 and 52
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Styria
Study officials:
References: