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

NCT04435600 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: M19-9772023-504156-10-00
• Study Type: interventional
• Target: 139
• Locations: 7 countries
• Sites: 53

Brief 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. 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: 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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Risankizumab; Ustekinumab; Psoriasis; Biologic; ABBV-066; SKYRIZI

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)

  The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

  Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)

  The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

  At Week 16 of initial treatment in each part of the study (Parts 1-4)

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

  The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

  Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Secondary Outcomes (16)

• Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)

  Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

• Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)

  Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)

  Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

  Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

• Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)

  Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Study Arms (5)

Part 1: Risankizumab Dose A

EXPERIMENTAL

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

Drug: Risankizumab

Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B

EXPERIMENTAL

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.

Drug: Risankizumab; Drug: Ustekinumab

Part 2: Risankizumab Dose A/B

EXPERIMENTAL

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).

Drug: Risankizumab

Part 3: Risankizumab Dose A/B

EXPERIMENTAL

Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.

Drug: Risankizumab

Part 4: Risankizumab Dose A/B

EXPERIMENTAL

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).

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous Injection

Also known as: SKYRIZI, ABBV-066

Part 1: Risankizumab Dose A; Part 2: Risankizumab Dose A/B; Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B; Part 3: Risankizumab Dose A/B; Part 4: Risankizumab Dose A/B

Ustekinumab DRUG

Subcutaneous Injection

Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (53)

UAB Department of Dermatology /ID# 218834

Birmingham, Alabama, 35233, United States

Location

First OC Dermatology /ID# 217733

Fountain Valley, California, 92708, United States

Location

Integrative Skin Science and Research /ID# 221741

Sacramento, California, 95815, United States

Location

University of California San Diego - Rady Children's Hospital San Diego /ID# 217906

San Diego, California, 92123, United States

Location

Rybear, Inc /ID# 223164

Fort Lauderdale, Florida, 33316-1952, United States

Location

Solutions Through Adv Rch /ID# 217936

Jacksonville, Florida, 32256, United States

Location

Olympian Clinical Research- St. Petersburg /ID# 217941

St. Petersburg, Florida, 33709-1405, United States

Location

Advanced Clinical Research Institute /ID# 222706

Tampa, Florida, 33607, United States

Location

University Dermatology and Vein Clinic, LLC /ID# 222778

Darien, Illinois, 60561, United States

Location

Duplicate_Arlington Dermatology /ID# 217472

Rolling Meadows, Illinois, 60008, United States

Location

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

Reno, Nevada, 89052, United States

Location

Duplicate_Forest Hills Dermatology Group /ID# 227941

Kew Gardens, New York, 11415, United States

Location

Univ Hosp Cleveland /ID# 228483

Cleveland, Ohio, 44106, United States

Location

The Ohio State University /ID# 217808

Columbus, Ohio, 43210, United States

Location

Apex Clinical Research Center /ID# 228537

Mayfield Heights, Ohio, 44124, United States

Location

Vital Prospects Clinical Research Institute, PC /ID# 217960

Tulsa, Oklahoma, 74136-7049, United States

Location

Medical University of South Carolina /ID# 217735

Charleston, South Carolina, 29425, United States

Location

Arlington Research Center, Inc /ID# 217471

Arlington, Texas, 76011, United States

Location

West Virginia University Hospitals /ID# 228352

Morgantown, West Virginia, 26506, United States

Location

Clinical Investigation Specialist, Inc - Kenosha /ID# 223161

Kenosha, Wisconsin, 53144-1782, United States

Location

Wisconsin Medical Center /ID# 240005

Milwaukee, Wisconsin, 53226, United States

Location

Duplicate_Dermatology Research Institute Inc. /ID# 226172

Calgary, Alberta, T2J 7E1, Canada

Location

Karma Clinical Trials /ID# 226177

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

Location

Hospital for Sick Children /ID# 226167

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte-Justine /ID# 226170

Montreal, Quebec, H3T 1C5, Canada

Location

Fachklinik Bad Bentheim /ID# 226014

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitaetsklinikum Bonn /ID# 228880

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitaetsklinikum Muenster /ID# 225988

Münster, North Rhine-Westphalia, 48149, Germany

Location

Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013

Kiel, Schleswig-Holstein, 24105, Germany

Location

Nagoya City University Hospital /ID# 230830

Nagoya, Aichi-ken, 467-8602, Japan

Location

Hiroshima University Hospital /ID# 256162

Hiroshima, Hiroshima, 734-8551, Japan

Location

Mie University Hospital /ID# 230836

Tsu, Mie-ken, 514-8507, Japan

Location

Kansai Medical University Hospital /ID# 231215

Hirakata-shi, Osaka, 573-1191, Japan

Location

Duplicate_Teikyo University Hospital /ID# 255188

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Tokyo Medical University Hospital /ID# 230575

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

High-Med Przychodnia Specjalistyczna /ID# 226060

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

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

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Dermoklinika Centrum Medyczne s.c. /ID# 226063

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Hospital Sant Joan de Deu /ID# 225722

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 225721

Madrid, 28007, Spain

Location

Hospital Universitario Infanta Leonor /ID# 225720

Madrid, 28031, Spain

Location

Hospital Universitario 12 de Octubre /ID# 227860

Madrid, 28041, Spain

Location

Complejo Hospitalario Universitario de Pontevedra /ID# 226061

Pontevedra, 36071, Spain

Location

Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078

Exeter, Devon, EX2 5DW, United Kingdom

Location

Duplicate_University Hospital Plymouth NHS Trust /ID# 227230

Plymouth, Devon, PL6 5FP, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust /ID# 227224

London, Greater London, SE1 9RT, United Kingdom

Location

Chelsea and Westminster Hospital /ID# 227231

London, Greater London, SW10 9NH, United Kingdom

Location

NHS Greater Glasgow and Clyde /ID# 227226

Glasgow, Scotland, G12 0XH, United Kingdom

Location

Frimley Health NHS Foundation Trust /ID# 229525

Camberley, Surrey, GU16 7UJ, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab; Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: July 14, 2020
• Primary Completion: February 12, 2024
• Study Completion: October 15, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DE (6); CA (4); JP (6); PL (5); ES (5); GB (6); US (21)