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

Last updated: June 14, 2024
Sponsor: AbbVie
Overall Status: Active - Enrolling

Phase

3

Condition

Skin Wounds

Rosacea

Warts

Treatment

Risankizumab

Clinical Study ID

NCT04862286
M19-973
2022-500408-22-00
  • Ages 6-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Risankizumab
Phase: 3
Study Start date:
July 24, 2021
Estimated Completion Date:
February 05, 2029

Connect with a study center

  • Dermatology Research Institute Inc. /ID# 233988

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Karma Clinical Trials /ID# 233985

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

    Site Not Available

  • Hospital for Sick Children /ID# 233986

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • CHU Sainte-Justine /ID# 233987

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Universitaetsklinikum Bonn /ID# 243910

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster /ID# 243905

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitaetsmedizin Mainz /ID# 243907

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim /ID# 243904

    Bad Bentheim, 48455
    Germany

    Site Not Available

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

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907

    Mainz, 55131
    Germany

    Site Not Available

  • Nagoya City University Hospital /ID# 248429

    Nagoya shi, Aichi 467-8602
    Japan

    Site Not Available

  • Mie University Hospital /ID# 263008

    Tsu, Mie 514-8507
    Japan

    Site Not Available

  • Kansai Medical University Hospital /ID# 252332

    Hirakata-shi, Osaka 573-1191
    Japan

    Site Not Available

  • Tokyo Medical University Hospital /ID# 252331

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

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

    Lodz, Lodzkie 90-265
    Poland

    Site Not Available

  • Dermoklinika Medical Center /ID# 243848

    Lodz, Lodzkie 90-436
    Poland

    Site Not Available

  • High-Med Przychodnia Specjalistyczna /ID# 243846

    Warszawa, Mazowieckie 01-817
    Poland

    Site Not Available

  • KSW nr1 w Rzeszowie /ID# 243850

    Rzeszow, Podkarpackie 35-055
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850

    Rzeszow, Podkarpackie 35-055
    Poland

    Site Not Available

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

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • Hospital Sant Joan de Deu /ID# 241103

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon /ID# 241099

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre /ID# 241102

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor /ID# 241100

    Madrid, 28031
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Pontevedra /ID# 241101

    Pontevedra, 36071
    Spain

    Site Not Available

  • Royal Devon & Exeter Hospital /ID# 245101

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • Royal Devon University Healthcare NHS Foundation Trust /ID# 245101

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • Derriford Hospital and the Royal Eye Infirmary /ID# 245104

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust /ID# 245100

    London, London, City Of SE1 9RT
    United Kingdom

    Site Not Available

  • Frimley Health NHS Foundation Trust /ID# 245105

    Camberley, GU16 7UJ
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • University Hospital Plymouth NHS Trust /ID# 245104

    Plymouth, PL6 5FP
    United Kingdom

    Site Not Available

  • UAB Department of Dermatology /ID# 252305

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • First OC Dermatology /ID# 226942

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 226108

    Sacramento, California 95815
    United States

    Site Not Available

  • University of California San Diego - Rady Children's Hospital San Diego /ID# 252348

    San Diego, California 92123
    United States

    Site Not Available

  • Solutions Through Adv Rch /ID# 226104

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Olympian Clinical Research - Largo /ID# 226106

    Largo, Florida 33770
    United States

    Site Not Available

  • Olympian Clinical Research- St. Petersburg /ID# 226106

    Saint Petersburg, Florida 33709-1405
    United States

    Site Not Available

  • Advanced Clinical Research Institute /ID# 248827

    Tampa, Florida 33607
    United States

    Site Not Available

  • University Dermatology and Vein Clinic, LLC /ID# 226100

    Darien, Illinois 60561
    United States

    Site Not Available

  • Arlington Dermatology /ID# 226097

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

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

    Reno, Nevada 89052
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute - Reno /ID# 248828

    Reno, Nevada 89509
    United States

    Site Not Available

  • Univ Hosp Cleveland /ID# 248825

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Apex Clinical Research Center /ID# 248830

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Apex Dermatology & Skin Surgery Center /ID# 248830

    Mayfield Heights, Ohio 44124-6509
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 248831

    Charleston, South Carolina 29425
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.