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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

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Karma Clinical Trials /ID# 233985
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St. John'sCanadaUnknown status
Hospital for Sick Children /ID# 233986
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TorontoCanadaUnknown status
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Carl Gustav Carus An Der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
University Medical Center Schleswig-Holstein
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KielGermanyRecruiting
Universitaetsmedizin Der Johannes Gutenberg-Universitat Mainz KöR
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MainzGermanyRecruiting
University Hospital Muenster AöR
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MuensterGermanyRecruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Gregorio Marañón University Hospital
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MadridSpainRecruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainRecruiting
Royal Devon & Exeter Hospital /ID# 245101
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ExeterUnited KingdomUnknown status
Chelsea and Westminster Hospital /ID# 245102
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LondonUnited KingdomUnknown status
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100
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LondonUnited KingdomUnknown status
Derriford Hospital and the Royal Eye Infirmary /ID# 245104
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PlymouthUnited KingdomUnknown status
Kansai Medical University Hirakata Hospital /ID# 252332
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Hirakata-shiJapanUnknown status
Nagoya City University Hospital /ID# 248429
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NagoyaJapanUnknown status
Tokyo Medical University Hospital /ID# 252331
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Shinjuku-kuJapanUnknown status
Mie University Hospital /ID# 263008
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TsuJapanUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandRecruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandRecruiting
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandRecruiting
Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
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WarsawPolandRecruiting
UAB Department of Dermatology /ID# 252305
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BirminghamUnited StatesUnknown status
Medical University of South Carolina /ID# 248831
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CharlestonUnited StatesUnknown status
Univ Hosp Cleveland /ID# 248825
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ClevelandUnited StatesUnknown status
University Dermatology and Vein Clinic, LLC /ID# 226100
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DarienUnited StatesUnknown status
First OC Dermatology /ID# 226942
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Fountain ValleyUnited StatesUnknown status
Solutions Through Adv Rch /ID# 226104
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JacksonvilleUnited StatesUnknown status
Apex Clinical Research Center /ID# 248830
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Mayfield HeightsUnited StatesUnknown status
Wisconsin Medical Center /ID# 263437
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MilwaukeeUnited StatesUnknown status
West Virginia University Hospitals /ID# 263438
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MorgantownUnited StatesUnknown status
Skin Cancer and Dermatology Institute - Reno /ID# 248828
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RenoUnited StatesUnknown status
Arlington Dermatology /ID# 226097
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Rolling MeadowsUnited StatesUnknown status
Integrative Skin Science and Research /ID# 226108
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SacramentoUnited StatesUnknown status
University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
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San DiegoUnited StatesUnknown status
Olympian Clinical Research- St. Petersburg /ID# 226106
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St. PetersburgUnited StatesUnknown status
Advanced Clinical Research Institute /ID# 248827
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.