A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
NCT ID: NCT04435600
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
139 participants
INTERVENTIONAL
2020-07-14
2024-10-15
Brief Summary
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Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.
Part 1: Participants aged 12 \< 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 \< 18 will receive;
* Period A: Risankizumab or ustekinumab based on body weight followed by;
* Period B: Risankizumab or no treatment.
* Period C: Re-treatment with risankizumab (if needed).
Part 3: Participants aged 6 \< 12 will receive risankizumab based on body weight.
Part 4: Participants aged 6 \< 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 \> 18 will receive risankizumab based on body weight).
Around 132 participants will be enrolled in approximately 50 sites worldwide.
Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.
Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.
Part 2:
* Period A: Risankizumab or ustekinumab for 16 weeks.
* Period B: Risankizumab or no treatment for 36 weeks.
* Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.
There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Part 1: Risankizumab Dose A
Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Risankizumab
Subcutaneous Injection
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B
Participants age 12 to less than 18 will receive:
Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Risankizumab Dose A or B based on body weight for 24 weeks.
Risankizumab
Subcutaneous Injection
Ustekinumab
Subcutaneous Injection
Part 2: Risankizumab Dose A/B
Participants age 12 to less than 18 will receive:
Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare.
Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Risankizumab
Subcutaneous Injection
Part 3: Risankizumab Dose A/B
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Risankizumab
Subcutaneous Injection
Part 4: Risankizumab Dose A/B
Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).
Risankizumab
Subcutaneous Injection
Interventions
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Risankizumab
Subcutaneous Injection
Ustekinumab
Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
* Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.
Exclusion Criteria
6 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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UAB Department of Dermatology /ID# 218834
Birmingham, Alabama, United States
First OC Dermatology /ID# 217733
Fountain Valley, California, United States
Integrative Skin Science and Research /ID# 221741
Sacramento, California, United States
University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
San Diego, California, United States
Rybear, Inc /ID# 223164
Fort Lauderdale, Florida, United States
Solutions Through Adv Rch /ID# 217936
Jacksonville, Florida, United States
Olympian Clinical Research- St. Petersburg /ID# 217941
St. Petersburg, Florida, United States
Advanced Clinical Research Institute /ID# 222706
Tampa, Florida, United States
University Dermatology and Vein Clinic, LLC /ID# 222778
Darien, Illinois, United States
Duplicate_Arlington Dermatology /ID# 217472
Rolling Meadows, Illinois, United States
Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738
Reno, Nevada, United States
Duplicate_Forest Hills Dermatology Group /ID# 227941
Kew Gardens, New York, United States
Univ Hosp Cleveland /ID# 228483
Cleveland, Ohio, United States
The Ohio State University /ID# 217808
Columbus, Ohio, United States
Apex Clinical Research Center /ID# 228537
Mayfield Heights, Ohio, United States
Vital Prospects Clinical Research Institute, PC /ID# 217960
Tulsa, Oklahoma, United States
Medical University of South Carolina /ID# 217735
Charleston, South Carolina, United States
Arlington Research Center, Inc /ID# 217471
Arlington, Texas, United States
West Virginia University Hospitals /ID# 228352
Morgantown, West Virginia, United States
Clinical Investigation Specialist, Inc - Kenosha /ID# 223161
Kenosha, Wisconsin, United States
Wisconsin Medical Center /ID# 240005
Milwaukee, Wisconsin, United States
Duplicate_Dermatology Research Institute Inc. /ID# 226172
Calgary, Alberta, Canada
Karma Clinical Trials /ID# 226177
St. John's, Newfoundland and Labrador, Canada
Hospital for Sick Children /ID# 226167
Toronto, Ontario, Canada
CHU Sainte-Justine /ID# 226170
Montreal, Quebec, Canada
Fachklinik Bad Bentheim /ID# 226014
Bad Bentheim, Lower Saxony, Germany
Universitaetsklinikum Bonn /ID# 228880
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster /ID# 225988
Münster, North Rhine-Westphalia, Germany
Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881
Dresden, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013
Kiel, Schleswig-Holstein, Germany
Nagoya City University Hospital /ID# 230830
Nagoya, Aichi-ken, Japan
Hiroshima University Hospital /ID# 256162
Hiroshima, Hiroshima, Japan
Mie University Hospital /ID# 230836
Tsu, Mie-ken, Japan
Kansai Medical University Hospital /ID# 231215
Hirakata-shi, Osaka, Japan
Duplicate_Teikyo University Hospital /ID# 255188
Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 230575
Shinjuku-ku, Tokyo, Japan
High-Med Przychodnia Specjalistyczna /ID# 226060
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
Gdansk, Pomeranian Voivodeship, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 226062
Lodz, Łódź Voivodeship, Poland
Dermoklinika Centrum Medyczne s.c. /ID# 226063
Lodz, Łódź Voivodeship, Poland
Hospital Sant Joan de Deu /ID# 225722
Esplugues de Llobregat, Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 225721
Madrid, , Spain
Hospital Universitario Infanta Leonor /ID# 225720
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 227860
Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 226061
Pontevedra, , Spain
Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078
Exeter, Devon, United Kingdom
Duplicate_University Hospital Plymouth NHS Trust /ID# 227230
Plymouth, Devon, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 227224
London, Greater London, United Kingdom
Chelsea and Westminster Hospital /ID# 227231
London, Greater London, United Kingdom
NHS Greater Glasgow and Clyde /ID# 227226
Glasgow, Scotland, United Kingdom
Frimley Health NHS Foundation Trust /ID# 229525
Camberley, Surrey, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2023-504156-10-00
Identifier Type: OTHER
Identifier Source: secondary_id
M19-977
Identifier Type: -
Identifier Source: org_study_id
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