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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
NCT04862286 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Risankizumab
Study Locations (20)
California
- First OC Dermatology /ID# 226942 — Fountain Valley
- Integrative Skin Science and Research /ID# 226108 — Sacramento
- University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 — San Diego
Florida
- Solutions Through Adv Rch /ID# 226104 — Jacksonville
- Olympian Clinical Research- St. Petersburg /ID# 226106 — St. Petersburg
- Advanced Clinical Research Institute /ID# 248827 — Tampa
Illinois
- University Dermatology and Vein Clinic, LLC /ID# 226100 — Darien
- Arlington Dermatology /ID# 226097 — Rolling Meadows
Ohio
- Univ Hosp Cleveland /ID# 248825 — Cleveland
- Apex Clinical Research Center /ID# 248830 — Mayfield Heights
North Rhine-Westphalia
- Universitaetsklinikum Bonn /ID# 243910 — Bonn
- Universitaetsklinikum Muenster /ID# 243905 — Münster
Alabama
- UAB Department of Dermatology /ID# 252305 — Birmingham
Nevada
- Skin Cancer and Dermatology Institute - Reno /ID# 248828 — Reno
South Carolina
- Medical University of South Carolina /ID# 248831 — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-07-24 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04862286
The ClinicalTrials.gov registry entry for NCT04862286 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 1 intervention — of which Risankizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04862286 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04862286 about?
NCT04862286 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04862286?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2021-07-24. Estimated completion is 2028-04.
What conditions does trial NCT04862286 study?
This clinical trial studies the following conditions: Psoriasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04862286?
The interventions under investigation include: Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04862286?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04862286 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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