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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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