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

Recruiting

• Conditions: Psoriasis; Psoriatic Arthritis

• Registration Number: NCT04433442
• Lead Sponsor: AbbVie

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Study Start: 2020-08-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants who Reported Adverse Events	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.

Trial Locations

Locations (63)

Dongguk University Ilsan Hospital /ID# 259337; 🇰🇷 Ilsan, Gyeonggido, Korea, Republic of

Gachon University Gil Medical Center /ID# 262788; 🇰🇷 Incheon, Gyeonggido, Korea, Republic of

Catholic Kwandong University International St.Mary's Hospital /ID# 262855; 🇰🇷 Incheon, Gyeonggido, Korea, Republic of

Uijeongbu Eulji Medical Center - Eulji University /ID# 259200; 🇰🇷 Uijeongbu, Gyeonggido, Korea, Republic of

Pusan National University Yangsan Hospital /ID# 259098; 🇰🇷 Yangsan-si, Gyeongsangnamdo, Korea, Republic of

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201; 🇰🇷 Uijeongbu, Gyeonggido, Korea, Republic of

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202; 🇰🇷 Uijeongbu, Gyeonggido, Korea, Republic of

The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826; 🇰🇷 부천시, Gyeonggido, Korea, Republic of

Chonnam National University Hospital /ID# 259199; 🇰🇷 동구, Jeonranamdo, Korea, Republic of

Dankook University Hospital /ID# 223995; 🇰🇷 Cheonan-si, Chungcheongnamdo, Korea, Republic of

Nowon Eulji Medical Center, Eulji University /ID# 259198; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital /ID# 262789; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital /ID# 270776; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Inje University - Busan Paik Hospital /ID# 238911; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Inje University Haeundae Hospital /ID# 238933; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Pusan National University Hospital /ID# 238896; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Chungbuk National University Hospital /ID# 238891; 🇰🇷 Cheongju, Chungcheongbugdo, Korea, Republic of

SoonChunHyang University Hospital Cheonan /ID# 238909; 🇰🇷 Cheonan-si, Chungcheongnamdo, Korea, Republic of

Kangwon National University Hospital /ID# 238902; 🇰🇷 Chuncheon, Gang Weondo, Korea, Republic of

Kyungpook National University Hospital /ID# 238915; 🇰🇷 중구, Daegu Gwang Yeogsi, Korea, Republic of

Chungnam National University Hospital /ID# 223993; 🇰🇷 Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of

Konyang University Hospital /ID# 238899; 🇰🇷 Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of

Korea University Ansan Hospital /ID# 223989; 🇰🇷 Ansan-si, Gyeonggido, Korea, Republic of

Ajou University Hospital /ID# 238920; 🇰🇷 Suwon-si, Gyeonggido, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon /ID# 238894; 🇰🇷 Bucheon-si, Gyeonggido, Korea, Republic of

Chungang University Hospital /ID# 238918; 🇰🇷 Dongjak-gu, Gyeonggido, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital /ID# 238927; 🇰🇷 Hwaseong, Gyeonggido, Korea, Republic of

Seoul National University Bundang Hospital /ID# 238900; 🇰🇷 Seongnam-si, Gyeonggido, Korea, Republic of

CHA Bundang Medical Center /ID# 238916; 🇰🇷 Seongnam, Gyeonggido, Korea, Republic of

Hallym University Sacred Heart Hospital /ID# 238913; 🇰🇷 Seoul, Gyeonggido, Korea, Republic of

Hallym University Sacred Heart Hospital /ID# 238930; 🇰🇷 Seoul, Gyeonggido, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital /ID# 248371; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of

Wonkwang University Hospital /ID# 238901; 🇰🇷 Iksan, Jeonrabugdo, Korea, Republic of

Chosun University Hospital /ID# 238910; 🇰🇷 Gwangju, Jeonranamdo, Korea, Republic of

Daegu Catholic University Medical Center /ID# 238921; 🇰🇷 Daegu, Gyeongsangbugdo, Korea, Republic of

Keimyung University Dongsan Hospital /ID# 238932; 🇰🇷 Daegu, Gyeongsangbugdo, Korea, Republic of

Dongguk University Gyeongju Hospital /ID# 238923; 🇰🇷 Gyeongju-si, Gyeongsangbugdo, Korea, Republic of

The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934; 🇰🇷 Incheon, Incheon Gwang Yeogsi, Korea, Republic of

Inha University Hospital /ID# 248373; 🇰🇷 Incheon, Incheon Gwang Yeogsi, Korea, Republic of

Design Hospital /ID# 238929; 🇰🇷 Jeollabuk-do, Jejudo, Korea, Republic of

Yongin Severance Hospital /ID# 238925; 🇰🇷 Yongin, Jejudo, Korea, Republic of

Inje University Sanggye Paik Hospital /ID# 238903; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Seoul Medical Center /ID# 238906; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

National Medical Center /ID# 238917; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Konkuk University Medical Center /ID# 223996; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

VHS(Veterans Health Service) Medical Center /ID# 238935; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Kyung Hee University Medical Center /ID# 248375; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Korea University Anam Hospital /ID# 238931; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Seoul National University Hospital /ID# 238904; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Kangbuk Samsung Hospital /ID# 238908; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Asan Medical Center /ID# 238912; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Gangnam Severance Hospital /ID# 223990; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

SMG-SNU Boramae Medical Center /ID# 238922; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 238919; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Korea University Guro Hospital /ID# 238905; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Kyungpook National University Chilgok Hospital /ID# 238914; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center /ID# 238924; 🇰🇷 Daegu, Korea, Republic of

Yonsei University Health System Severance Hospital /ID# 238928; 🇰🇷 Seoul, Korea, Republic of

Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369; 🇰🇷 Seoul, Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital /ID# 238936; 🇰🇷 Seoul, Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital /ID# 238937; 🇰🇷 Seoul, Korea, Republic of