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

Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Risankizumab (Skyrizi) in Adult Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04433442

Enrollment

2324

Registered

2020-06-16

Start date

2020-08-04

Completion date

2025-06-13

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis, Psoriatic Arthritis

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results