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

NCT04433442 | Completed

• 1 other identifier: P20-271
• Study Type: observational
• Target: 2,324
• Locations: 1 country
• Sites: 63

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.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

Psoriasis; Plaque Psoriasis; Psoriatic Arthritis; Risankizumab; Skyrizi; Prefilled syringe

Outcome Measures

Primary Outcomes (1)

• Number of Participants who Reported Adverse Events

  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

Study Arms (1)

Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants with moderate to severe plaque psoriasis or psoriatic arthritis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (63)

Inje University - Busan Paik Hospital /ID# 238911

Busan, Busan Gwang Yeogsi, 47392, South Korea

Location

Inje University Haeundae Hospital /ID# 238933

Busan, Busan Gwang Yeogsi, 48108, South Korea

Location

Pusan National University Hospital /ID# 238896

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Dankook University Hospital /ID# 223995

Cheonan-si, Chungcheongnam-do, 31116, South Korea

Location

SoonChunHyang University Hospital Cheonan /ID# 238909

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

Kyungpook National University Hospital /ID# 238915

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Chungnam National University Hospital /ID# 223993

Daejeon, Daejeon Gwang Yeogsi, 35015, South Korea

Location

Konyang University Hospital /ID# 238899

Daejeon, Daejeon Gwang Yeogsi, 35365, South Korea

Location

Kangwon National University Hospital /ID# 238902

Chuncheon, Gang Weondo, 24289, South Korea

Location

Korea University Ansan Hospital /ID# 223989

Ansan-si, Gyeonggido, 15355, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 238894

Bucheon-si, Gyeonggido, 14584, South Korea

Location

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

Bucheon-si, Gyeonggido, 14647, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital /ID# 238927

Hwaseong, Gyeonggido, 18450, South Korea

Location

Dongguk University Ilsan Hospital /ID# 259337

Ilsan, Gyeonggido, 10326, South Korea

Location

Gachon University Gil Medical Center /ID# 262788

Incheon, Gyeonggido, 21565, South Korea

Location

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

Incheon, Gyeonggido, 22711, South Korea

Location

CHA Bundang Medical Center /ID# 238916

Seongnam, Gyeonggido, 13496, South Korea

Location

Seoul National University Bundang Hospital /ID# 238900

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Hallym University Sacred Heart Hospital /ID# 238913

Seoul, Gyeonggido, 14067, South Korea

Location

Hallym University Sacred Heart Hospital /ID# 238930

Seoul, Gyeonggido, 14067, South Korea

Location

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

Suwon, Gyeonggido, 16247, South Korea

Location

Ajou University Hospital /ID# 238920

Suwon, Gyeonggido, 16499, South Korea

Location

Uijeongbu Eulji Medical Center - Eulji University /ID# 259200

Uijeongbu-si, Gyeonggido, 11759, South Korea

Location

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

Uijeongbu-si, Gyeonggido, 11765, South Korea

Location

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

Uijeongbu-si, Gyeonggido, 11765, South Korea

Location

Yongin Severance Hospital /ID# 238925

Yŏngin, Gyeonggido, 16995, South Korea

Location

Daegu Catholic University Medical Center /ID# 238921

Daegu, Gyeongsangbuk-do, 42472, South Korea

Location

Keimyung University Dongsan Hospital /ID# 238932

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Dongguk University Gyeongju Hospital /ID# 238923

Gyeongju, Gyeongsangbuk-do, 38067, South Korea

Location

Pusan National University Yangsan Hospital /ID# 259098

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

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

Incheon, Incheon Gwang Yeogsi, 21431, South Korea

Location

Inha University Hospital /ID# 248373

Incheon, Incheon Gwang Yeogsi, 21565, South Korea

Location

Wonkwang University Hospital /ID# 238901

Iksan, Jeonrabugdo, 54538, South Korea

Location

Design Hospital /ID# 238929

Jeollabuk-do, Jeonrabugdo, 54910, South Korea

Location

Chosun University Hospital /ID# 238910

Gwangju, Jeonranamdo, 61453, South Korea

Location

Chonnam National University Hospital /ID# 259199

Gwangju, Jeonranamdo, 61469, South Korea

Location

Chungbuk National University Hospital /ID# 238891

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Chungang University Hospital /ID# 238918

Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea

Location

Inje University Sanggye Paik Hospital /ID# 238903

Seoul, Seoul Teugbyeolsi, 01757, South Korea

Location

Nowon Eulji Medical Center, Eulji University /ID# 259198

Seoul, Seoul Teugbyeolsi, 01830, South Korea

Location

Seoul Medical Center /ID# 238906

Seoul, Seoul Teugbyeolsi, 02053, South Korea

Location

Kyung Hee University Hospital /ID# 248375

Seoul, Seoul Teugbyeolsi, 02447, South Korea

Location

Korea University Anam Hospital /ID# 238931

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Seoul National University Hospital /ID# 238904

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Kangbuk Samsung Hospital /ID# 238908

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

National Medical Center /ID# 238917

Seoul, Seoul Teugbyeolsi, 04564, South Korea

Location

Konkuk University Medical Center /ID# 223996

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 05368, South Korea

Location

Asan Medical Center /ID# 238912

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Gangnam Severance Hospital /ID# 223990

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

Samsung Medical Center /ID# 238919

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 238922

Seoul, Seoul Teugbyeolsi, 07061, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 07345, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 262789

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 270776

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Korea University Guro Hospital /ID# 238905

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

Kyungpook National University Chilgok Hospital /ID# 238914

Daegu, 41404, South Korea

Location

Yeungnam University Medical Center /ID# 238924

Daegu, 42415, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 238928

Seoul, 03722, South Korea

Location

Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369

Seoul, 05278, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital /ID# 238936

Seoul, 05355, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital /ID# 238937

Seoul, 05355, South Korea

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint 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: June 4, 2020
• First Posted: June 16, 2020
• Study Start: August 4, 2020
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (63)