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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04433442
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Psoriatic Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

: Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cheonan-si, Chungcheongnamdo, Korea, Republic of

Status

Recruiting

Address

SoonChunHyang University CheonAn Hospital /ID# 238909

Cheonan-si, Chungcheongnamdo, 31151

Ansan, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Korea University Ansan Hospital /ID# 223989

Ansan, Gyeonggido, 15355

Anyang, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Hallym University Sacred Heart Hospital /ID# 238913

Anyang, Gyeonggido, 14068

Anyang, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Hallym University Sacred Heart Hospital /ID# 238930

Anyang, Gyeonggido, 14068

Buncheon, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

SoonChunHyang University Buchon Hospital /ID# 238894

Buncheon, Gyeonggido, 14584

Hwaseong, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Dongtan Sacred Heart Hospital /ID# 238927

Hwaseong, Gyeonggido, 18450

Seongnam si, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

CHA University Bundang Medical Center /ID# 238916

Seongnam si, Gyeonggido, 13496

Seongnam, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital /ID# 238900

Seongnam, Gyeonggido, 13620

Suwon, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, ST. Vincent's Hospital /ID# 248371

Suwon, Gyeonggido, 16247

Ajou University Hospital /ID# 238920, Suwon, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital /ID# 238920

Suwon, Gyeonggido, 16499

Wonkwang University Hospital /Id# 238901, Iksan, Jeonrabugdo, Korea, Republic of

Status

Recruiting

Address

Wonkwang University Hospital /Id# 238901

Iksan, Jeonrabugdo, 54538

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

Status

Recruiting

Address

Kangbuk Samsung Hospital /ID# 238908

Seoul, Seoul Teugbyeolsi, 03181

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Yonsei University Health System Severance Hospital /ID# 238928

Seoul, Seoul Teugbyeolsi, 03722

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

KonKuk University Medical Center /ID# 223996

Seoul, Seoul Teugbyeolsi, 05030

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

SMG-SNU Boramae Medical Center /ID# 238922

Seoul, Seoul Teugbyeolsi, 07061

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Korea Universtiy Guro Hospital /ID# 238905

Seoul, Seoul Teugbyeolsi, 08308

Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Busan Paik Hospital /ID# 238911

Busan, , 47392

Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Haeundae Hospital /ID# 238933

Busan, , 48108

Busan, Korea, Republic of

Status

Recruiting

Address

Pusan National University Hospital /ID# 238896

Busan, , 49241

Dankook University Hospital /ID# 223995, Cheonan, Korea, Republic of

Status

Recruiting

Address

Dankook University Hospital /ID# 223995

Cheonan, , 31116

Cheongju, Korea, Republic of

Status

Recruiting

Address

Chungbuk National University Hospital /ID# 238891

Cheongju, , 28644

Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Chilgok Hospital /ID# 238914

Daegu, , 41404

Daegu, Korea, Republic of

Status

Recruiting

Address

Keimyung University Dongsan Medical Center /ID# 238932

Daegu, , 41931

Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Hospital /ID# 238915

Daegu, , 41944

Daegu, Korea, Republic of

Status

Recruiting

Address

Yeungnam University Medical Center /ID# 238924

Daegu, , 42415

Daegu, Korea, Republic of

Status

Recruiting

Address

Daegu Catholic University Medical Center /ID# 238921

Daegu, , 42472

Daejeon, Korea, Republic of

Status

Recruiting

Address

Chungnam National University Hospital /ID# 223993

Daejeon, , 35015

Konyang University Hospital /ID# 238899, Daejeon, Korea, Republic of

Status

Recruiting

Address

Konyang University Hospital /ID# 238899

Daejeon, , 35365

Chosun University Hospital /ID# 238910, Gwangju, Korea, Republic of

Status

Recruiting

Address

Chosun University Hospital /ID# 238910

Gwangju, , 61453

Gyeongsangbuk-do, Korea, Republic of

Status

Recruiting

Address

Dongguk University Gyeongju Hospital /ID# 238923

Gyeongsangbuk-do, , 38067

Incheon, Korea, Republic of

Status

Recruiting

Address

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

Incheon, , 21431

Inha University Hospital /ID# 248373, Incheon, Korea, Republic of

Status

Recruiting

Address

Inha University Hospital /ID# 248373

Incheon, , 22332

Design Hospital /ID# 238929, Jeollabuk-do, Korea, Republic of

Status

Recruiting

Address

Design Hospital /ID# 238929

Jeollabuk-do, , 54910

Kangwondo, Korea, Republic of

Status

Recruiting

Address

Kangwon National University Hospital /ID# 238902

Kangwondo, , 24289

Seoul, Korea, Republic of

Status

Recruiting

Address

Inje University Sanggye Paik Hospital /ID# 238903

Seoul, , 01755

Seoul Medical Center /ID# 238906, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul Medical Center /ID# 238906

Seoul, , 02053

Seoul, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Medical Center /ID# 248375

Seoul, , 02447

Seoul, Korea, Republic of

Status

Recruiting

Address

Korea University Anam Hospital /ID# 238931

Seoul, , 02841

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital /ID# 238904

Seoul, , 03080

National Medical Center /ID# 238917, Seoul, Korea, Republic of

Status

Recruiting

Address

National Medical Center /ID# 238917

Seoul, , 04564

Seoul, Korea, Republic of

Status

Completed

Address

Kyunghee University Hospital at Gangdong /ID# 248369

Seoul, , 05278

Seoul, Korea, Republic of

Status

Recruiting

Address

Kangdong Sacred Heart Hospital /ID# 238936

Seoul, , 05355

Seoul, Korea, Republic of

Status

Recruiting

Address

Kangdong Sacred Heart Hospital /ID# 238937

Seoul, , 05355

Seoul, Korea, Republic of

Status

Recruiting

Address

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

Seoul, , 05368

Asan Medical Center /ID# 238912, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center /ID# 238912

Seoul, , 05505

Gangnam Severance Hospital /ID# 223990, Seoul, Korea, Republic of

Status

Recruiting

Address

Gangnam Severance Hospital /ID# 223990

Seoul, , 06273

Samsung Medical Center /ID# 238919, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center /ID# 238919

Seoul, , 06351

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 248370

Seoul, , 06591

Seoul, Korea, Republic of

Status

Recruiting

Address

Chung-Ang University Hostipal /ID# 238918

Seoul, , 06973

Seoul, Korea, Republic of

Status

Recruiting

Address

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

Seoul, , 07345

Yongin Severance Hospital /ID# 238925, Yongin, Korea, Republic of

Status

Recruiting

Address

Yongin Severance Hospital /ID# 238925

Yongin, , 16995

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