Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Study Purpose

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977. Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide. Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.

Exclusion Criteria:

--Participants who have developed any discontinuation criteria as defined in Study M19-977.

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.

NCT04862286
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.

Phase 3
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 Enrolling by invitation
Countries Canada, Germany, Japan, Poland, Spain, United Kingdom, United States
Conditions

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

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Risankizumab

Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.

Interventions

Drug: - Risankizumab

Subcutaneous (SC) injection.

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.

First OC Dermatology /ID# 226942, Fountain Valley, California

Status

Address

First OC Dermatology /ID# 226942

Fountain Valley, California, 92708-3701

Sacramento, California

Status

Address

Integrative Skin Science and Research /ID# 226108

Sacramento, California, 95815-4500

Solutions Through Adv Rch /ID# 226104, Jacksonville, Florida

Status

Address

Solutions Through Adv Rch /ID# 226104

Jacksonville, Florida, 32256

Saint Petersburg, Florida

Status

Address

Olympian Clinical Research- St. Petersburg /ID# 226106

Saint Petersburg, Florida, 33709-1405

Tampa, Florida

Status

Address

Advanced Clinical Research Institute /ID# 248827

Tampa, Florida, 33607-6429

Darien, Illinois

Status

Address

University Dermatology and Vein Clinic, LLC /ID# 226100

Darien, Illinois, 60561

Arlington Dermatology /ID# 226097, Rolling Meadows, Illinois

Status

Address

Arlington Dermatology /ID# 226097

Rolling Meadows, Illinois, 60008

Reno, Nevada

Status

Address

Skin Cancer and Dermatology Institute (SCDI) /ID# 248828

Reno, Nevada, 89052

Univ Hosp Cleveland /ID# 248825, Cleveland, Ohio

Status

Address

Univ Hosp Cleveland /ID# 248825

Cleveland, Ohio, 44106

Mayfield Heights, Ohio

Status

Address

Apex Dermatology & Skin Surgery Center /ID# 248830

Mayfield Heights, Ohio, 44124-6509

Charleston, South Carolina

Status

Address

Medical University of South Carolina /ID# 248831

Charleston, South Carolina, 29425

International Sites

Calgary, Alberta, Canada

Status

Address

Dermatology Research Institute Inc. /ID# 233988

Calgary, Alberta, T2J 7E1

Karma Clinical Trials /ID# 233985, St. John's, Newfoundland and Labrador, Canada

Status

Address

Karma Clinical Trials /ID# 233985

St. John's, Newfoundland and Labrador, A1A 4Y3

Hospital for Sick Children /ID# 233986, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children /ID# 233986

Toronto, Ontario, M5G 1X8

CHU Sainte-Justine /ID# 233987, Montreal, Quebec, Canada

Status

Address

CHU Sainte-Justine /ID# 233987

Montreal, Quebec, H3T 1C5

Muenster, Nordrhein-Westfalen, Germany

Status

Address

Universitaetsklinikum Muenster /ID# 243905

Muenster, Nordrhein-Westfalen, 48149

Kiel, Schleswig-Holstein, Germany

Status

Address

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883

Kiel, Schleswig-Holstein, 24105

Fachklinik Bad Bentheim /ID# 243904, Bad Bentheim, Germany

Status

Address

Fachklinik Bad Bentheim /ID# 243904

Bad Bentheim, , 48455

Universitaetsklinikum Bonn /ID# 243910, Bonn, Germany

Status

Address

Universitaetsklinikum Bonn /ID# 243910

Bonn, , 53127

Dresden, Germany

Status

Address

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908

Dresden, , 01307

Mainz, Germany

Status

Address

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907

Mainz, , 55131

Nagoya shi, Aichi, Japan

Status

Address

Nagoya City University Hospital /ID# 248429

Nagoya shi, Aichi, 467-8602

Lodz, Lodzkie, Poland

Status

Address

Dermed Centrum Medyczne Sp. z o.o /ID# 243847

Lodz, Lodzkie, 90-265

Dermoklinika Medical Center /ID# 243848, Lodz, Lodzkie, Poland

Status

Address

Dermoklinika Medical Center /ID# 243848

Lodz, Lodzkie, 90-436

Warszawa, Mazowieckie, Poland

Status

Address

High-Med Przychodnia Specjalistyczna /ID# 243846

Warszawa, Mazowieckie, 01-817

KSW nr1 w Rzeszowie /ID# 243850, Rzeszow, Podkarpackie, Poland

Status

Address

KSW nr1 w Rzeszowie /ID# 243850

Rzeszow, Podkarpackie, 35-055

Gdansk, Pomorskie, Poland

Status

Address

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849

Gdansk, Pomorskie, 80-546

Hospital Sant Joan de Deu /ID# 241103, Esplugues de Llobregat, Barcelona, Spain

Status

Address

Hospital Sant Joan de Deu /ID# 241103

Esplugues de Llobregat, Barcelona, 08950

Madrid, Spain

Status

Address

Hospital General Universitario Gregorio Maranon /ID# 241099

Madrid, , 28007

Madrid, Spain

Status

Address

Hospital Universitario Infanta Leonor /ID# 241100

Madrid, , 28031

Madrid, Spain

Status

Address

Hospital Universitario 12 de Octubre /ID# 241102

Madrid, , 28041

Pontevedra, Spain

Status

Address

Complejo Hospitalario Universitario de Pontevedra /ID# 241101

Pontevedra, , 36071

Exeter, Devon, United Kingdom

Status

Address

Royal Devon University Healthcare NHS Foundation Trust /ID# 245101

Exeter, Devon, EX2 5DW

London, London, City Of, United Kingdom

Status

Address

Guys and St Thomas NHS Foundation Trust /ID# 245100

London, London, City Of, SE1 9RT

Camberley, United Kingdom

Status

Address

Frimley Health NHS Foundation Trust /ID# 245105

Camberley, , GU16 7UJ

London, United Kingdom

Status

Address

Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102

London, , SW10 9NH

Plymouth, United Kingdom

Status

Address

University Hospital Plymouth NHS Trust /ID# 245104

Plymouth, , PL6 5FP

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