Clinical trial NCT04435600: A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Official title: A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Risankizumab
Ustekinumab
Psoriasis
Biologic
ABBV-066
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 139
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
measure: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
timeFrame: At Week 16 of initial treatment in each part of the study (Parts 1-4)
measure: 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
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
measure: Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
measure: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: 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
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)
measure: Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
timeFrame: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
timeFrame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
measure: Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
timeFrame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
measure: Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
timeFrame: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)
measure: Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)
timeFrame: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Dermatology /ID# 218834
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology /ID# 217733
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 221741
state: California
city: San Diego
country: United States
facility: University of California San Diego - Rady Children's Hospital San Diego /ID# 217906
state: California
city: Fort Lauderdale
country: United States
facility: Rybear, Inc /ID# 223164
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 217936
state: Florida
city: Saint Petersburg
country: United States
facility: Olympian Clinical Research- St. Petersburg /ID# 217941
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 222706
state: Florida
city: Darien
country: United States
facility: University Dermatology and Vein Clinic, LLC /ID# 222778
state: Illinois
city: Rolling Meadows
country: United States
facility: Duplicate_Arlington Dermatology /ID# 217472
state: Illinois
city: Reno
country: United States
facility: Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738
state: Nevada
city: Kew Gardens
country: United States
facility: Duplicate_Forest Hills Dermatology Group /ID# 227941
state: New York
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 228483
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 217808
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center /ID# 228537
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC /ID# 217960
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 217735
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 217471
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 228352
state: West Virginia
city: Kenosha
country: United States
facility: Clinical Investigation Specialist, Inc - Kenosha /ID# 223161
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 240005
state: Wisconsin
city: Calgary
country: Canada
facility: Duplicate_Dermatology Research Institute Inc. /ID# 226172
state: Alberta
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 226177
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Hospital for Sick Children /ID# 226167
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine /ID# 226170
state: Quebec
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 226014
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 228880
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 225988
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013
state: Schleswig-Holstein
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 230830
state: Aichi
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 256162
state: Hiroshima
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 230836
state: Mie
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 231215
state: Osaka
city: Itabashi-ku
country: Japan
facility: Duplicate_Teikyo University Hospital /ID# 255188
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 230575
state: Tokyo
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o /ID# 226062
state: Lodzkie
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. /ID# 226063
state: Lodzkie
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna /ID# 226060
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116
state: Podkarpackie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252
state: Pomorskie
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 225722
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 225721
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 225720
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 227860
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra /ID# 226061
city: Exeter
country: United Kingdom
facility: Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078
state: Devon
city: Plymouth
country: United Kingdom
facility: Duplicate_University Hospital Plymouth NHS Trust /ID# 227230
state: Devon
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 227224
state: Greater London
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital /ID# 227231
state: Greater London
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 227226
state: Scotland
city: Camberley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust /ID# 229525
state: Surrey
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: