Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi Prefilled Syringe for Injection) in Adult Participants With Moderate to Severe Plaque Psoriasis

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. 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 and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Around 3000 adult participants with a moderate to severe plaque psoriasis 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
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants with Moderate to Severe Plaque Psoriasis

Participants will receive risankizumab (prefilled syringe for injection) 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

Ansan-si, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Korea University Ansan Hospital /ID# 223989

Ansan-si, Gyeonggido, 15355

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

Status

Recruiting

Address

Gangnam Severance Hospital /ID# 223990

Seoul, Seoul Teugbyeolsi, 06273

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.