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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT04862286
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 24, 2021
Status verified
Aug 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Risankizumab
    Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: Up to approximately 224 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
UAB Department of Dermatology /ID# 252305BirminghamAlabama35233-
First OC Dermatology /ID# 226942Fountain ValleyCalifornia92708-
Integrative Skin Science and Research /ID# 226108SacramentoCalifornia95815-
University of California San Diego - Rady Children's Hospital San Diego /ID# 252348San DiegoCalifornia92123-
Solutions Through Adv Rch /ID# 226104JacksonvilleFlorida32256-
Olympian Clinical Research- St. Petersburg /ID# 226106St. PetersburgFlorida33709-1405-
Advanced Clinical Research Institute /ID# 248827TampaFlorida33607-
University Dermatology and Vein Clinic, LLC /ID# 226100DarienIllinois60561-
Arlington Dermatology /ID# 226097Rolling MeadowsIllinois60008-
Skin Cancer and Dermatology Institute - Reno /ID# 248828RenoNevada89509-
Univ Hosp Cleveland /ID# 248825ClevelandOhio44106-
Apex Clinical Research Center /ID# 248830Mayfield HeightsOhio44124-
Medical University of South Carolina /ID# 248831CharlestonSouth Carolina29425-
West Virginia University Hospitals /ID# 263438MorgantownWest Virginia26506-
Wisconsin Medical Center /ID# 263437MilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
UAB Department of Dermatology· Birmingham, ALFirst OC Dermatology· Fountain Valley, CAIntegrative Skin Science and Research· Sacramento, CAUniversity of California San Diego - Rady Children's Hospital San Diego· San Diego, CASolutions Through Adv Rch· Jacksonville, FLOlympian Clinical Research- St. Petersburg· St. Petersburg, FL

Related Studies