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
Public ClinicalTrials.gov record NCT04862286. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04862286
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 23, 2021
- Primary completion
- Mar 31, 2028
- Completion
- Mar 31, 2028
- Last update posted
- Aug 11, 2025
2021 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Department of Dermatology /ID# 252305 | Birmingham | Alabama | 35233 | — |
| First OC Dermatology /ID# 226942 | Fountain Valley | California | 92708 | — |
| Integrative Skin Science and Research /ID# 226108 | Sacramento | California | 95815 | — |
| University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 | San Diego | California | 92123 | — |
| Solutions Through Adv Rch /ID# 226104 | Jacksonville | Florida | 32256 | — |
| Olympian Clinical Research- St. Petersburg /ID# 226106 | St. Petersburg | Florida | 33709-1405 | — |
| Advanced Clinical Research Institute /ID# 248827 | Tampa | Florida | 33607 | — |
| University Dermatology and Vein Clinic, LLC /ID# 226100 | Darien | Illinois | 60561 | — |
| Arlington Dermatology /ID# 226097 | Rolling Meadows | Illinois | 60008 | — |
| Skin Cancer and Dermatology Institute - Reno /ID# 248828 | Reno | Nevada | 89509 | — |
| Univ Hosp Cleveland /ID# 248825 | Cleveland | Ohio | 44106 | — |
| Apex Clinical Research Center /ID# 248830 | Mayfield Heights | Ohio | 44124 | — |
| Medical University of South Carolina /ID# 248831 | Charleston | South Carolina | 29425 | — |
| West Virginia University Hospitals /ID# 263438 | Morgantown | West Virginia | 26506 | — |
| Wisconsin Medical Center /ID# 263437 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04862286, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04862286 live on ClinicalTrials.gov.