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PsoriasisNCT04433442

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

An observational study of Psoriasis and Psoriatic Arthritis, run by AbbVie at 63 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Psoriasis, Psoriatic Arthritis
How many people
2,324 participants
Where
63 sitesSouth Korea
Study dates
4 Aug 2020to 13 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants with moderate to severe plaque psoriasis or psoriatic arthritis

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

South Korea63 sites

  • Korea University Ansan Hospital /ID# 223989

    Ansan-si, Gyeonggido, 15355

  • Soon Chun Hyang University Hospital Bucheon /ID# 238894

    Bucheon-si, Gyeonggido, 14584

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

    Bucheon-si, Gyeonggido, 14647

  • Inje University - Busan Paik Hospital /ID# 238911

    Busan, Busan Gwang Yeogsi, 47392

  • Inje University Haeundae Hospital /ID# 238933

    Busan, Busan Gwang Yeogsi, 48108

  • Pusan National University Hospital /ID# 238896

    Busan, Busan Gwang Yeogsi, 49241

  • Dankook University Hospital /ID# 223995

    Cheonan-si, Chungcheongnam-do, 31116

  • SoonChunHyang University Hospital Cheonan /ID# 238909

    Cheonan-si, Chungcheongnam-do, 31151

  • Chungbuk National University Hospital /ID# 238891

    Cheongju-si, North Chungcheong, 28644

  • Kangwon National University Hospital /ID# 238902

    Chuncheon, Gang Weondo, 24289

  • Kyungpook National University Hospital /ID# 238915

    Daegu, Daegu Gwang Yeogsi, 41944

  • Daegu Catholic University Medical Center /ID# 238921

    Daegu, Gyeongsangbuk-do, 42472

  • Keimyung University Dongsan Hospital /ID# 238932

    Daegu, Gyeongsangbuk-do, 42601

  • Kyungpook National University Chilgok Hospital /ID# 238914

    Daegu, 41404

  • Yeungnam University Medical Center /ID# 238924

    Daegu, 42415

  • Chungnam National University Hospital /ID# 223993

    Daejeon, Daejeon Gwang Yeogsi, 35015

  • Konyang University Hospital /ID# 238899

    Daejeon, Daejeon Gwang Yeogsi, 35365

  • Chungang University Hospital /ID# 238918

    Dongjak-gu, Seoul Teugbyeolsi, 06973

  • Chosun University Hospital /ID# 238910

    Gwangju, Jeonranamdo, 61453

  • Chonnam National University Hospital /ID# 259199

    Gwangju, Jeonranamdo, 61469

  • Dongguk University Gyeongju Hospital /ID# 238923

    Gyeongju, Gyeongsangbuk-do, 38067

  • Hallym University Dongtan Sacred Heart Hospital /ID# 238927

    Hwaseong, Gyeonggido, 18450

  • Wonkwang University Hospital /ID# 238901

    Iksan, Jeonrabugdo, 54538

  • Dongguk University Ilsan Hospital /ID# 259337

    Ilsan, Gyeonggido, 10326

  • Gachon University Gil Medical Center /ID# 262788

    Incheon, Gyeonggido, 21565

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

    Incheon, Gyeonggido, 22711

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

    Incheon, Incheon Gwang Yeogsi, 21431

  • Inha University Hospital /ID# 248373

    Incheon, Incheon Gwang Yeogsi, 21565

  • Design Hospital /ID# 238929

    Jeollabuk-do, Jeonrabugdo, 54910

  • CHA Bundang Medical Center /ID# 238916

    Seongnam, Gyeonggido, 13496

  • Seoul National University Bundang Hospital /ID# 238900

    Seongnam-si, Gyeonggido, 13620

  • Hallym University Sacred Heart Hospital /ID# 238913

    Seoul, Gyeonggido, 14067

  • Hallym University Sacred Heart Hospital /ID# 238930

    Seoul, Gyeonggido, 14067

  • Inje University Sanggye Paik Hospital /ID# 238903

    Seoul, Seoul Teugbyeolsi, 01757

  • Nowon Eulji Medical Center, Eulji University /ID# 259198

    Seoul, Seoul Teugbyeolsi, 01830

  • Seoul Medical Center /ID# 238906

    Seoul, Seoul Teugbyeolsi, 02053

  • Kyung Hee University Hospital /ID# 248375

    Seoul, Seoul Teugbyeolsi, 02447

  • Korea University Anam Hospital /ID# 238931

    Seoul, Seoul Teugbyeolsi, 02841

  • Seoul National University Hospital /ID# 238904

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 238908

    Seoul, Seoul Teugbyeolsi, 03181

  • National Medical Center /ID# 238917

    Seoul, Seoul Teugbyeolsi, 04564

  • Konkuk University Medical Center /ID# 223996

    Seoul, Seoul Teugbyeolsi, 05030

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

    Seoul, Seoul Teugbyeolsi, 05368

  • Asan Medical Center /ID# 238912

    Seoul, Seoul Teugbyeolsi, 05505

  • Gangnam Severance Hospital /ID# 223990

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 238919

    Seoul, Seoul Teugbyeolsi, 06351

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

    Seoul, Seoul Teugbyeolsi, 06591

  • SMG-SNU Boramae Medical Center /ID# 238922

    Seoul, Seoul Teugbyeolsi, 07061

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

    Seoul, Seoul Teugbyeolsi, 07345

  • Hallym University Kangnam Sacred Heart Hospital /ID# 262789

    Seoul, Seoul Teugbyeolsi, 07441

  • Hallym University Kangnam Sacred Heart Hospital /ID# 270776

    Seoul, Seoul Teugbyeolsi, 07441

  • Korea University Guro Hospital /ID# 238905

    Seoul, Seoul Teugbyeolsi, 08308

  • Yonsei University Health System Severance Hospital /ID# 238928

    Seoul, 03722

  • Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369

    Seoul, 05278

  • Hallym University Kangdong Sacred Heart Hospital /ID# 238936

    Seoul, 05355

  • Hallym University Kangdong Sacred Heart Hospital /ID# 238937

    Seoul, 05355

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

    Suwon, Gyeonggido, 16247

  • Ajou University Hospital /ID# 238920

    Suwon, Gyeonggido, 16499

  • Uijeongbu Eulji Medical Center - Eulji University /ID# 259200

    Uijeongbu-si, Gyeonggido, 11759

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

    Uijeongbu-si, Gyeonggido, 11765

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

    Uijeongbu-si, Gyeonggido, 11765

  • Pusan National University Yangsan Hospital /ID# 259098

    Yangsan, Gyeongsangnam-do, 50612

  • Yongin Severance Hospital /ID# 238925

    Yŏngin, Gyeonggido, 16995

Other trials in South Korea

About this study

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

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.

Read more

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.

Keywords
Psoriasis, Plaque Psoriasis, Psoriatic Arthritis, Risankizumab, Skyrizi, Prefilled syringe
Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04433442
Study groupRoleWhat they receive
Moderate to Severe Plaque Psoriasis or Psoriatic ArthritisParticipants will receive risankizumab as prescribed by the physician in routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start4 Aug 2020
  3. Primary completion13 Jun 2025
  4. Study completion13 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433442
Sponsor's protocol ID
P20-271
Status last verified
Apr 2026
First submitted
4 Jun 2020
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis and Psoriatic Arthritis, run by AbbVie at 63 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants who Reported Adverse Events (time frame: Up to Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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