NCT04862286Active, not recruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 26 Apr 2021
- Start date
- Jul 2021
- Primary completion date
- Apr 2028
- Lead sponsor
- AbbVie
- Diseases
- Psoriasis
- NCT number
- NCT04862286
- EU CT number
- 2022-500408-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 132
- From Jul 2021 to the primary completion date, Apr 2028
- 41 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- --Participants who have developed any discontinuation criteria as defined in Study M19-977.
Who the study is looking for
- --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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karma Clinical Trials /ID# 233985 Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Hospital for Sick Children /ID# 233986 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus An Der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| University Medical Center Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Universitaetsmedizin Der Johannes Gutenberg-Universitat Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| University Hospital Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Gregorio Marañón University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Recruiting |
| Royal Devon & Exeter Hospital /ID# 245101 Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Chelsea and Westminster Hospital /ID# 245102 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Derriford Hospital and the Royal Eye Infirmary /ID# 245104 Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Kansai Medical University Hirakata Hospital /ID# 252332 Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Unknown status |
| Nagoya City University Hospital /ID# 248429 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Tokyo Medical University Hospital /ID# 252331 Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Mie University Hospital /ID# 263008 Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| UAB Department of Dermatology /ID# 252305 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Medical University of South Carolina /ID# 248831 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Univ Hosp Cleveland /ID# 248825 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University Dermatology and Vein Clinic, LLC /ID# 226100 Coordinator of this site? Confirm its status | Darien | United States | Unknown status |
| First OC Dermatology /ID# 226942 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Solutions Through Adv Rch /ID# 226104 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Apex Clinical Research Center /ID# 248830 Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Wisconsin Medical Center /ID# 263437 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| West Virginia University Hospitals /ID# 263438 Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Skin Cancer and Dermatology Institute - Reno /ID# 248828 Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Arlington Dermatology /ID# 226097 Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| Integrative Skin Science and Research /ID# 226108 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of California San Diego - Rady Children's Hospital San Diego /ID# 252348 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Olympian Clinical Research- St. Petersburg /ID# 226106 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Advanced Clinical Research Institute /ID# 248827 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.