Study to Assess the Change in Disease State When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Taiwan

NCT04818385 | Completed

• 1 other identifier: P20-272
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 8

Brief Summary

Psoriasis (PsO) is a chronic, disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques and is associated with high burden of illness that results in a negative impact on long-term health outcomes including quality of life (QoL). The main objective of this study is to characterize the durability of response of risankizumab compared to other biologics measured by the Psoriasis Area and Severity Index (PASI) 90 response in adult participants with moderate to severe chronic plaque psoriasis who are either new or have used a biological treatment in the past. Risankizumab is a drug approved for the treatment of moderate-to-severe plaque psoriasis. Participants who are prescribed risankizumab or other comparator drugs in the real world setting are enrolled in this study. Data from a total of approximately 240 participants; 160 using risankizumab and 80 using other biologics will be evaluated across Taiwan. Participants will receive subcutaneous risankizumab injection or or other biologic as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Conditions

Psoriasis

Keywords

Psoriasis; Risankizumab; Skyrizi; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants who Achieved Psoriasis Area and Severity Index (PASI) 90

  The PASI is defined based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 90% reduction. The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing complete erythroderma of the severest degree.

  Week 24

Secondary Outcomes (18)

• Time of First Treatment Change

  Up to Week 108

• The Percentage of Participants who Achieved PASI 75

  Up to Week 108

• The Percentage of Participants who Achieved PASI 90

  Up to Week 108

• The Percentage of Participants who Achieved PASI 100

  Up to Week 108

• Percentage of Participants who Achieved Absolute PASI<=5

  Up to Week 108

Study Arms (2)

Participants Receiving Risankizumab

Participants will receive risankizumab as prescribed by their physician.

Participants Receiving All Other Biologics

Participants will receive all other biologics as prescribed by their physician.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderate to severe plaque psoriasis.

You may qualify if:

• Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist t at the time of recruitment.
• Initiating an approved biologic treatment for psoriasis as per regulatory and reimbursement policy in Taiwan. Physician's decision with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
• Treatments prescribed in accordance to both the product monograph, regulatory and reimbursement policies in Taiwan.

You may not qualify if:

• \- Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in another PMOS or Registry is acceptable.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

National Taiwan University Hospital /ID# 230017

Taipei City, Taipei, 100, Taiwan

Location

National Taiwan University Hospital - Hsinchu branch /ID# 238432

Hsinchu, 30059, Taiwan

Location

Hualien Tzu Chi Hospital /ID# 238431

Hualien City, 97002, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 230016

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital /ID# 229961

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital /ID# 253776

Tainan, 704, Taiwan

Location

Taipei Medical University Hospital /ID# 230018

Taipei, 11031, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 253775

Taoyuan, 333, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: May 31, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

TW (8)