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

NCT ID: NCT04433442

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2025-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis

Participants will receive risankizumab as prescribed by the physician in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Inje University - Busan Paik Hospital /ID# 238911

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Inje University Haeundae Hospital /ID# 238933

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Pusan National University Hospital /ID# 238896

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Dankook University Hospital /ID# 223995

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

SoonChunHyang University Hospital Cheonan /ID# 238909

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

Kyungpook National University Hospital /ID# 238915

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Chungnam National University Hospital /ID# 223993

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status

Konyang University Hospital /ID# 238899

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status

Kangwon National University Hospital /ID# 238902

Chuncheon, Gang Weondo, South Korea

Site Status

Korea University Ansan Hospital /ID# 223989

Ansan-si, Gyeonggido, South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon /ID# 238894

Bucheon-si, Gyeonggido, South Korea

Site Status

The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826

Bucheon-si, Gyeonggido, South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital /ID# 238927

Hwaseong, Gyeonggido, South Korea

Site Status

Dongguk University Ilsan Hospital /ID# 259337

Ilsan, Gyeonggido, South Korea

Site Status

Gachon University Gil Medical Center /ID# 262788

Incheon, Gyeonggido, South Korea

Site Status

Catholic Kwandong University International St.Mary's Hospital /ID# 262855

Incheon, Gyeonggido, South Korea

Site Status

CHA Bundang Medical Center /ID# 238916

Seongnam, Gyeonggido, South Korea

Site Status

Seoul National University Bundang Hospital /ID# 238900

Seongnam-si, Gyeonggido, South Korea

Site Status

Hallym University Sacred Heart Hospital /ID# 238913

Seoul, Gyeonggido, South Korea

Site Status

Hallym University Sacred Heart Hospital /ID# 238930

Seoul, Gyeonggido, South Korea

Site Status

The Catholic University Of Korea St. Vincent's Hospital /ID# 248371

Suwon, Gyeonggido, South Korea

Site Status

Ajou University Hospital /ID# 238920

Suwon, Gyeonggido, South Korea

Site Status

Uijeongbu Eulji Medical Center - Eulji University /ID# 259200

Uijeongbu-si, Gyeonggido, South Korea

Site Status

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201

Uijeongbu-si, Gyeonggido, South Korea

Site Status

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202

Uijeongbu-si, Gyeonggido, South Korea

Site Status

Yongin Severance Hospital /ID# 238925

Yŏngin, Gyeonggido, South Korea

Site Status

Daegu Catholic University Medical Center /ID# 238921

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Keimyung University Dongsan Hospital /ID# 238932

Daegu, Gyeongsangbuk-do, South Korea

Site Status

Dongguk University Gyeongju Hospital /ID# 238923

Gyeongju, Gyeongsangbuk-do, South Korea

Site Status

Pusan National University Yangsan Hospital /ID# 259098

Yangsan, Gyeongsangnam-do, South Korea

Site Status

The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status

Inha University Hospital /ID# 248373

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status

Wonkwang University Hospital /ID# 238901

Iksan, Jeonrabugdo, South Korea

Site Status

Design Hospital /ID# 238929

Jeollabuk-do, Jeonrabugdo, South Korea

Site Status

Chosun University Hospital /ID# 238910

Gwangju, Jeonranamdo, South Korea

Site Status

Chonnam National University Hospital /ID# 259199

Gwangju, Jeonranamdo, South Korea

Site Status

Chungbuk National University Hospital /ID# 238891

Cheongju-si, North Chungcheong, South Korea

Site Status

Chungang University Hospital /ID# 238918

Dongjak-gu, Seoul Teugbyeolsi, South Korea

Site Status

Inje University Sanggye Paik Hospital /ID# 238903

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Nowon Eulji Medical Center, Eulji University /ID# 259198

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Seoul Medical Center /ID# 238906

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Kyung Hee University Hospital /ID# 248375

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Korea University Anam Hospital /ID# 238931

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Seoul National University Hospital /ID# 238904

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Kangbuk Samsung Hospital /ID# 238908

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

National Medical Center /ID# 238917

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Konkuk University Medical Center /ID# 223996

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

VHS(Veterans Health Service) Medical Center /ID# 238935

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Asan Medical Center /ID# 238912

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Gangnam Severance Hospital /ID# 223990

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 238919

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

SMG-SNU Boramae Medical Center /ID# 238922

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital /ID# 262789

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital /ID# 270776

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Korea University Guro Hospital /ID# 238905

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Kyungpook National University Chilgok Hospital /ID# 238914

Daegu, , South Korea

Site Status

Yeungnam University Medical Center /ID# 238924

Daegu, , South Korea

Site Status

Yonsei University Health System Severance Hospital /ID# 238928

Seoul, , South Korea

Site Status

Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369

Seoul, , South Korea

Site Status

Hallym University Kangdong Sacred Heart Hospital /ID# 238936

Seoul, , South Korea

Site Status

Hallym University Kangdong Sacred Heart Hospital /ID# 238937

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P20-271

Identifier Type: -

Identifier Source: org_study_id

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