A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
- Registration Number
- NCT04435600
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Risankizumab Dose A/B Risankizumab 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). Part 3: Risankizumab Dose A/B Risankizumab Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks. Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B Ustekinumab 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. Part 1: Risankizumab Dose A Risankizumab Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks. Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B Risankizumab 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. Part 4: Risankizumab Dose A/B Risankizumab 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI) Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) 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 complete erythroderma of the severest degree.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear At Week 16 of each part of the study (Parts 1-4) 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).
US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline At Week 16 of each part of the study (Parts 1-4) 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).
- Secondary Outcome Measures
Name Time Method Part 2 (Period C): Change in Itch NRS Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) 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 complete erythroderma of the severest degree.
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) 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 complete erythroderma of the severest degree.
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) Baseline (Week 0) to Week 16 of each part of the study (Parts 1-4) 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 complete erythroderma of the severest degree.
Part 2 (Period C): Percentage of Participants sPGA Clear or Almost Clear Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C) 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).
Part 2 (Period C): US Only: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) Clear or Almost Clear and with at least 2 grade improvement from baseline Baseline (Week 0) to Week 16 upon start of re-treatment in Part 2 (Period C) 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).
Part 2 (Period C): Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI) Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) 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 complete erythroderma of the severest degree.
Part 2 (Period C): Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI) Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) 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 complete erythroderma of the severest degree.
Part 2 (Period C): Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI) Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) 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 complete erythroderma of the severest degree.
Part 2 (Period C): Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI) Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) 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 complete erythroderma of the severest degree.
Part 2 (Period A): Change in Children's Dermatology Life Quality Index (CDLQI) Baseline (Week 0) to Week 16 in Part 2 (Period A) The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL).
Part 2 (Period C): Change in CDLQI Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL.
Part 2 (Period A): Change in Family Dermatology Life Quality Index (FDLQI) Baseline (Week 0) to Week 16 in Part 2 (Period A) The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.
Part 2 (Period C): Change in FDLQI Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on QOL of family members.
Part 2 (Period C): Change in Itch Numerical Rating Scale (Itch NRS) Baseline (Week 0) to Week 16 upon starting re-treatment in Part 2 (Period C) The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
Part 2 (Period A): Percentage of Participants Achieving > = 4-point Improvement in the Itch Numerical Rating Scale (in Participants with Baseline Score > = 4) at Each Study Visit Baseline (Week 0) to Week 16 in Part 2 (Period A) The itch NRS is an 11-points scale that subjects will complete to describe the intensity of their itch using a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable."
Trial Locations
- Locations (53)
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881
🇩🇪Dresden, Sachsen, Germany
Duplicate_Teikyo University Hospital /ID# 255188
🇯🇵Itabashi-ku, Tokyo, Japan
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
UAB Department of Dermatology /ID# 218834
🇺🇸Birmingham, Alabama, 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
🇺🇸Saint 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
Univ Hosp Cleveland /ID# 228483
🇺🇸Cleveland, Ohio, United States
The Ohio State University /ID# 217808
🇺🇸Columbus, 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
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, Niedersachsen, Germany
Universitaetsklinikum Bonn /ID# 228880
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster /ID# 225988
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013
🇩🇪Kiel, Schleswig-Holstein, Germany
Nagoya City University Hospital /ID# 230830
🇯🇵Nagoya shi, Aichi, Japan
Hiroshima University Hospital /ID# 256162
🇯🇵Hiroshima-shi, Hiroshima, Japan
Kansai Medical University Hospital /ID# 231215
🇯🇵Hirakata-shi, Osaka, Japan
Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987
🇩🇪Mainz, Rheinland-Pfalz, Germany
First OC Dermatology /ID# 217733
🇺🇸Fountain Valley, California, 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
Apex Clinical Research Center /ID# 228537
🇺🇸Mayfield Heights, Ohio, United States
Wisconsin Medical Center /ID# 240005
🇺🇸Milwaukee, Wisconsin, United States
Duplicate_Dermatology Research Institute Inc. /ID# 226172
🇨🇦Calgary, Alberta, Canada
Tokyo Medical University Hospital /ID# 230575
🇯🇵Shinjuku-ku, Tokyo, Japan
Dermed Centrum Medyczne Sp. z o.o /ID# 226062
🇵🇱Lodz, Lodzkie, Poland
Mie University Hospital /ID# 230836
🇯🇵Tsu-shi, Mie, Japan
High-Med Przychodnia Specjalistyczna /ID# 226060
🇵🇱Warszawa, Mazowieckie, Poland
Dermoklinika Centrum Medyczne s.c. /ID# 226063
🇵🇱Lodz, Lodzkie, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
🇵🇱Rzeszow, Podkarpackie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
🇵🇱Gdansk, Pomorskie, 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
Guys and St Thomas NHS Foundation Trust /ID# 227224
🇬🇧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
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 227231
🇬🇧London, United Kingdom