A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

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. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. 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 and Part 4: Participants aged 6 < 12 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.

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:

  • - Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
  • - 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:

  • - Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

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.

NCT04435600
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 Recruiting
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: Part 1: Risankizumab Dose A

Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.

Experimental: 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.

Experimental: 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).

Experimental: 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.

Experimental: 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.

Interventions

Drug: - Risankizumab

Subcutaneous Injection

Drug: - Ustekinumab

Subcutaneous 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.

Birmingham, Alabama

Status

Not yet recruiting

Address

UAB Department of Dermatology /ID# 218834

Birmingham, Alabama, 35233

First OC Dermatology /ID# 217733, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology /ID# 217733

Fountain Valley, California, 92708-3701

Sacramento, California

Status

Recruiting

Address

Integrative Skin Science and Research /ID# 221741

Sacramento, California, 95815-4500

San Diego, California

Status

Not yet recruiting

Address

Rady Children's Hospital San Diego /ID# 217906

San Diego, California, 92123

Rybear, Inc /ID# 223164, Fort Lauderdale, Florida

Status

Recruiting

Address

Rybear, Inc /ID# 223164

Fort Lauderdale, Florida, 33316-1952

Solutions Through Adv Rch /ID# 217936, Jacksonville, Florida

Status

Recruiting

Address

Solutions Through Adv Rch /ID# 217936

Jacksonville, Florida, 32256

Largo, Florida

Status

Recruiting

Address

Olympian Clinical Research - Largo /ID# 217941

Largo, Florida, 33770

Tampa, Florida

Status

Not yet recruiting

Address

Advanced Clinical Research Institute /ID# 222706

Tampa, Florida, 33607-6429

Darien, Illinois

Status

Recruiting

Address

University Dermatology and Vein Clinic, LLC /ID# 222778

Darien, Illinois, 60561

Arlington Dermatology /ID# 217472, Rolling Meadows, Illinois

Status

Recruiting

Address

Arlington Dermatology /ID# 217472

Rolling Meadows, Illinois, 60008

Reno, Nevada

Status

Recruiting

Address

Skin Cancer and Dermatology Institute (SCDI) /ID# 221738

Reno, Nevada, 89052

Kew Gardens, New York

Status

Recruiting

Address

Forest Hills Dermatology Group /ID# 227941

Kew Gardens, New York, 11415

Univ Hosp Cleveland /ID# 228483, Cleveland, Ohio

Status

Not yet recruiting

Address

Univ Hosp Cleveland /ID# 228483

Cleveland, Ohio, 44106

The Ohio State University /ID# 217808, Columbus, Ohio

Status

Recruiting

Address

The Ohio State University /ID# 217808

Columbus, Ohio, 43210

Mayfield Heights, Ohio

Status

Not yet recruiting

Address

Apex Dermatology & Skin Surgery Center /ID# 228537

Mayfield Heights, Ohio, 44124-6509

Tulsa, Oklahoma

Status

Completed

Address

Vital Prospects Clinical Research Institute, PC /ID# 217960

Tulsa, Oklahoma, 74136-7049

Charleston, South Carolina

Status

Not yet recruiting

Address

Medical University of South Carolina /ID# 217735

Charleston, South Carolina, 29425

Arlington, Texas

Status

Recruiting

Address

Arlington Research Center, Inc /ID# 217471

Arlington, Texas, 76011

Morgantown, West Virginia

Status

Not yet recruiting

Address

West Virginia University Hospitals /ID# 228352

Morgantown, West Virginia, 26506

Kenosha, Wisconsin

Status

Completed

Address

Clinical Investigation Specialist, Inc - Kenosha /ID# 223161

Kenosha, Wisconsin, 53144-1782

International Sites

Calgary, Alberta, Canada

Status

Not yet recruiting

Address

Dermatology Research Institute Inc. /ID# 226172

Calgary, Alberta, T2J 7E1

Karma Clinical Trials /ID# 226177, St. John's, Newfoundland and Labrador, Canada

Status

Not yet recruiting

Address

Karma Clinical Trials /ID# 226177

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

Hospital for Sick Children /ID# 226167, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Hospital for Sick Children /ID# 226167

Toronto, Ontario, M5G 1X8

CHU Sainte-Justine /ID# 226170, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

CHU Sainte-Justine /ID# 226170

Montreal, Quebec, H3T 1C5

Universitatsklinikum Munster /ID# 225988, Munster, Niedersachsen, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Munster /ID# 225988

Munster, Niedersachsen, 48149

Kiel, Schleswig-Holstein, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013

Kiel, Schleswig-Holstein, 24105

Fachklinik Bad Bentheim /ID# 226014, Bad Bentheim, Germany

Status

Not yet recruiting

Address

Fachklinik Bad Bentheim /ID# 226014

Bad Bentheim, , 48455

Universitaetsklinikum Bonn /ID# 228880, Bonn, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Bonn /ID# 228880

Bonn, , 53127

Dresden, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 228881

Dresden, , 01307

Hamburg, Germany

Status

Not yet recruiting

Address

Katholisches Kinderkrankenhaus Wilhelmstift /ID# 217442

Hamburg, , 22149

Mainz, Germany

Status

Not yet recruiting

Address

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987

Mainz, , 55131

Nagoya shi, Aichi, Japan

Status

Not yet recruiting

Address

Nagoya City University Hospital /ID# 230830

Nagoya shi, Aichi, 467-8602

Mie University Hospital /ID# 230836, Tsu-shi, Mie, Japan

Status

Not yet recruiting

Address

Mie University Hospital /ID# 230836

Tsu-shi, Mie, 514-8507

Hirakata-shi, Osaka, Japan

Status

Recruiting

Address

Kansai Medical University Hospital /ID# 231215

Hirakata-shi, Osaka, 573-1191

Shinjuku-ku, Tokyo, Japan

Status

Not yet recruiting

Address

Tokyo Medical University Hospital /ID# 230575

Shinjuku-ku, Tokyo, 160-0023

Lodz, Lodzkie, Poland

Status

Not yet recruiting

Address

Dermed Centrum Medyczne Sp. z o.o /ID# 226062

Lodz, Lodzkie, 90-265

Lodz, Lodzkie, Poland

Status

Not yet recruiting

Address

Dermoklinika Centrum Medyczne s.c. /ID# 226063

Lodz, Lodzkie, 90-436

Warszawa, Mazowieckie, Poland

Status

Not yet recruiting

Address

Dorota Bystrzanowska HIGH-MED Przychodnia Specjalistyczna /ID# 226060

Warszawa, Mazowieckie, 01-817

KSW nr1 w Rzeszowie /ID# 226116, Rzeszow, Podkarpackie, Poland

Status

Not yet recruiting

Address

KSW nr1 w Rzeszowie /ID# 226116

Rzeszow, Podkarpackie, 35-055

Gdansk, Pomorskie, Poland

Status

Not yet recruiting

Address

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252

Gdansk, Pomorskie, 80-546

Hospital Sant Joan de Deu /ID# 225722, Esplugues de Llobregat, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Sant Joan de Deu /ID# 225722

Esplugues de Llobregat, Barcelona, 08950

Madrid, Spain

Status

Not yet recruiting

Address

Hospital General Universitario Gregorio Maranon /ID# 225721

Madrid, , 28007

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Infanta Leonor /ID# 225720

Madrid, , 28031

Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario 12 de Octubre /ID# 227860

Madrid, , 28041

Pontevedra, Spain

Status

Recruiting

Address

Complejo Hospitalario Universitario de Pontevedra /ID# 226061

Pontevedra, , 36071

Exeter, Devon, United Kingdom

Status

Not yet recruiting

Address

Royal Devon and Exeter NHS Trust Hospital /ID# 228078

Exeter, Devon, EX2 5DW

London, London, City Of, United Kingdom

Status

Recruiting

Address

Guy's and St Thomas' NHS Foundation Trust /ID# 227224

London, London, City Of, SE1 9RT

Glasgow, Scotland, United Kingdom

Status

Recruiting

Address

NHS Greater Glasgow and Clyde /ID# 227226

Glasgow, Scotland, G12 0XH

Camberley, United Kingdom

Status

Recruiting

Address

Frimley Health NHS Foundation Trust /ID# 229525

Camberley, , GU16 7UJ

London, United Kingdom

Status

Not yet recruiting

Address

Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 227231

London, , SW10 9NH

Plymouth, United Kingdom

Status

Not yet recruiting

Address

University Hospital Plymouth NHS Foundation Trust /ID# 227230

Plymouth, , PL6 8DH

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