Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece

Launched by ABBVIE · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called risankizumab for people who have recently been diagnosed with moderate plaque psoriasis, a skin condition that causes red, itchy patches. The trial aims to gather information about how well this drug works over both short and long periods of time, focusing on patients' experiences and quality of life. To participate, individuals must have been diagnosed with moderate plaque psoriasis within the last two years, not have tried advanced treatments before, and have specific skin severity scores as determined by a doctor.

Participants in the study will receive risankizumab as prescribed by their dermatologist and will be monitored for about two years. They can expect to attend regular visits at local clinics or hospitals, which will follow standard care procedures. There won’t be any extra burdens from being in the trial, and those who are pregnant, breastfeeding, or currently using other experimental treatments will not be eligible to join. This study is important for understanding how risankizumab can help improve the lives of those affected by moderate plaque psoriasis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Participants with a confirmed diagnosis of moderate plaque PsO made by a specialist ≤24 months prior to risankizumab prescription defined as:
• • Percentage of body surface affected by PsO Body Surface Area (BSA) \>2% and \<20%
• • Psoriasis Area and Severity Index (PASI) score \>10
• • Static Physician's Global Assessment (sPGA) score =3 (moderate) based on a 5-point scale (0-4)
• • Participants naïve to advanced treatments (biologics, apremilast, and deucravacitinib)
• • Participants who have been prescribed treatment with risankizumab in line with marketing authorization and local access conditions, prior to signed Informed Consent
• • Decision to treat with risankizumab has been made independently and prior to enrolment in the study
• • Participants must be willing and able to read and complete the study specific questionnaires
• Exclusion Criteria:
• • Participants who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days before risankizumab initiation
• • Pregnancy or lactation
• • Unwilling or unable to provide informed consent