Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi) in Adult Participants With Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

April 22, 2026 updated by: AbbVie

Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Risankizumab (Skyrizi) in Adult Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis Patients

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis or psoriatic arthritis and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis. Around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across Korea. The sample size for this study is a requirement by local authorities.

Participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician.

There is expected to be no additional burden for participants in this study. All study visits will occur during routine clinical practice and participants will be followed for 52 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital /ID# 238914
      • Daegu, South Korea, 42415
        • Yeungnam University Medical Center /ID# 238924
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 238928
      • Seoul, South Korea, 05278
        • Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369
      • Seoul, South Korea, 05355
        • Hallym University Kangdong Sacred Heart Hospital /ID# 238936
      • Seoul, South Korea, 05355
        • Hallym University Kangdong Sacred Heart Hospital /ID# 238937
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 47392
        • Inje University - Busan Paik Hospital /ID# 238911
      • Busan, Busan Gwang Yeogsi, South Korea, 48108
        • Inje University Haeundae Hospital /ID# 238933
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Pusan National University Hospital /ID# 238896
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, South Korea, 31116
        • Dankook University Hospital /ID# 223995
      • Cheonan-si, Chungcheongnam-do, South Korea, 31151
        • SoonChunHyang University Hospital Cheonan /ID# 238909
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
        • Kyungpook National University Hospital /ID# 238915
    • Daejeon Gwang Yeogsi
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
        • Chungnam National University Hospital /ID# 223993
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35365
        • Konyang University Hospital /ID# 238899
    • Gang Weondo
      • Chuncheon, Gang Weondo, South Korea, 24289
        • Kangwon National University Hospital /ID# 238902
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital /ID# 223989
      • Bucheon-si, Gyeonggido, South Korea, 14584
        • Soon Chun Hyang University Hospital Bucheon /ID# 238894
      • Bucheon-si, Gyeonggido, South Korea, 14647
        • The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826
      • Hwaseong, Gyeonggido, South Korea, 18450
        • Hallym University Dongtan Sacred Heart Hospital /ID# 238927
      • Ilsan, Gyeonggido, South Korea, 10326
        • Dongguk University Ilsan Hospital /ID# 259337
      • Incheon, Gyeonggido, South Korea, 21565
        • Gachon University Gil Medical Center /ID# 262788
      • Incheon, Gyeonggido, South Korea, 22711
        • Catholic Kwandong University International St.Mary's Hospital /ID# 262855
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 238916
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 238900
      • Seoul, Gyeonggido, South Korea, 14067
        • Hallym University Sacred Heart Hospital /ID# 238913
      • Seoul, Gyeonggido, South Korea, 14067
        • Hallym University Sacred Heart Hospital /ID# 238930
      • Suwon, Gyeonggido, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital /ID# 248371
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 238920
      • Uijeongbu-si, Gyeonggido, South Korea, 11759
        • Uijeongbu Eulji Medical Center - Eulji University /ID# 259200
      • Uijeongbu-si, Gyeonggido, South Korea, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201
      • Uijeongbu-si, Gyeonggido, South Korea, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202
      • Yŏngin, Gyeonggido, South Korea, 16995
        • Yongin Severance Hospital /ID# 238925
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42472
        • Daegu Catholic University Medical Center /ID# 238921
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 238932
      • Gyeongju, Gyeongsangbuk-do, South Korea, 38067
        • Dongguk University Gyeongju Hospital /ID# 238923
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital /ID# 259098
    • Incheon Gwang Yeogsi
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21565
        • Inha University Hospital /ID# 248373
    • Jeonrabugdo
      • Iksan, Jeonrabugdo, South Korea, 54538
        • Wonkwang University Hospital /ID# 238901
      • Jeollabuk-do, Jeonrabugdo, South Korea, 54910
        • Design Hospital /ID# 238929
    • Jeonranamdo
      • Gwangju, Jeonranamdo, South Korea, 61453
        • Chosun University Hospital /ID# 238910
      • Gwangju, Jeonranamdo, South Korea, 61469
        • Chonnam National University Hospital /ID# 259199
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital /ID# 238891
    • Seoul Teugbyeolsi
      • Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
        • Chungang University Hospital /ID# 238918
      • Seoul, Seoul Teugbyeolsi, South Korea, 01757
        • Inje University Sanggye Paik Hospital /ID# 238903
      • Seoul, Seoul Teugbyeolsi, South Korea, 01830
        • Nowon Eulji Medical Center, Eulji University /ID# 259198
      • Seoul, Seoul Teugbyeolsi, South Korea, 02053
        • Seoul Medical Center /ID# 238906
      • Seoul, Seoul Teugbyeolsi, South Korea, 02447
        • Kyung Hee University Hospital /ID# 248375
      • Seoul, Seoul Teugbyeolsi, South Korea, 02841
        • Korea University Anam Hospital /ID# 238931
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 238904
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Kangbuk Samsung Hospital /ID# 238908
      • Seoul, Seoul Teugbyeolsi, South Korea, 04564
        • National Medical Center /ID# 238917
      • Seoul, Seoul Teugbyeolsi, South Korea, 05030
        • Konkuk University Medical Center /ID# 223996
      • Seoul, Seoul Teugbyeolsi, South Korea, 05368
        • VHS(Veterans Health Service) Medical Center /ID# 238935
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 238912
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital /ID# 223990
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 238919
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370
      • Seoul, Seoul Teugbyeolsi, South Korea, 07061
        • SMG-SNU Boramae Medical Center /ID# 238922
      • Seoul, Seoul Teugbyeolsi, South Korea, 07345
        • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 262789
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 270776
      • Seoul, Seoul Teugbyeolsi, South Korea, 08308
        • Korea University Guro Hospital /ID# 238905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult participants with moderate to severe plaque psoriasis or psoriatic arthritis

Description

Inclusion Criteria:

  • Suitable for the treatment with risankizumab according to the approved local label.
  • Voluntarily agree to participate in this study and sign informed consent.

Exclusion Criteria:

- Contraindications to risankizumab as listed on the approved local label.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis
Participants will receive risankizumab as prescribed by the physician in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Reported Adverse Events
Time Frame: Up to Week 72
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Actual)

June 13, 2025

Study Completion (Actual)

June 13, 2025

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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