Clinical trial NCT04862286: Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977
Official title: OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Risankizumab
SKYRIZI
ABBV-066
BI 655066
Risankizumab-rzaa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.

Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.

Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.

Exclusion Criteria:

--Participants who have developed any discontinuation criteria as defined in Study M19-977.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to approximately 224 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Dermatology /ID# 252305
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology /ID# 226942
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 226108
state: California
city: San Diego
country: United States
facility: University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
state: California
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 226104
state: Florida
city: Saint Petersburg
country: United States
facility: Olympian Clinical Research- St. Petersburg /ID# 226106
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 248827
state: Florida
city: Darien
country: United States
facility: University Dermatology and Vein Clinic, LLC /ID# 226100
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 226097
state: Illinois
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno /ID# 248828
state: Nevada
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 248825
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center /ID# 248830
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 248831
state: South Carolina
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 233985
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Hospital for Sick Children /ID# 233986
state: Ontario
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn /ID# 243910
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 243905
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz /ID# 243907
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
state: Schleswig-Holstein
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim /ID# 243904
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 248429
state: Aichi
city: Tsu
country: Japan
facility: Mie University Hospital /ID# 263008
state: Mie
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 252332
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 252331
state: Tokyo
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o /ID# 243847
state: Lodzkie
city: Lodz
country: Poland
facility: Dermoklinika Medical Center /ID# 243848
state: Lodzkie
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna /ID# 243846
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
state: Podkarpackie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
state: Pomorskie
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 241103
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 241099
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 241100
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 241102
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra /ID# 241101
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital /ID# 245101
state: Devon
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 245104
state: Devon
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 245100
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: