A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)

Genital Psoriasis Clinical Trial

Official title:

Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029257
• Other study ID #: CZATCH-2023
• Status: Recruiting
• Start date: November 14, 2023
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Almirall, S.A.
• Contact: Senior Director Regional Medical Affairs
• Phone: +43 0 15953960
• Email: medicalat[@]almirall.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Psoriasis
• Psoriasis

Intervention

Drug:
• Tildrakizumab
As provided in real-world clinical practice.

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Week 52
Primary	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.	Baseline up to Week 52
Secondary	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).	Baseline, Week 4, 16, 28 and 52
Secondary	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".	Baseline, Week 4, 16, 28 and 52
Secondary	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.	Baseline, Week 4, 16, 28 and 52
Secondary	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.	At Week 28 and 52
Secondary	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.	Baseline, Week 28 and 52
Secondary	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.	Baseline, Week 4, 16, 28 and 52
Secondary	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	Baseline, Week 28 and 52