Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis

Not yet recruiting

• Conditions: Plaque Psoriasis

• Registration Number: NCT07039110
• Lead Sponsor: AbbVie

Brief Summary

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.

Risankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide.

Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-09-30
• Primary Completion: 2028-03
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.
• Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines.
• Decision to treat with risankizumab is made prior to and independently of study participation.

Exclusion Criteria

• History of a sleep disorder diagnosis which the patient is currently being treated for.
• Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.
• Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1	At 12 months	DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no at all) to 1 (a little).