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

Active, not 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

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: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2324

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 & 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)

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

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

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

Kyungpook National University Hospital /ID# 238915; 🇰🇷 Daegu, 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

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

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