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
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)
2 other identifiers
interventional
132
7 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2021
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Start
First participant enrolled
July 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
August 12, 2025
August 1, 2025
6.7 years
April 26, 2021
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Up to approximately 224 weeks
Study Arms (1)
Risankizumab
EXPERIMENTALParticipants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
Interventions
Subcutaneous (SC) injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants who have developed any discontinuation criteria as defined in Study M19-977.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (41)
UAB Department of Dermatology /ID# 252305
Birmingham, Alabama, 35233, United States
First OC Dermatology /ID# 226942
Fountain Valley, California, 92708, United States
Integrative Skin Science and Research /ID# 226108
Sacramento, California, 95815, United States
University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
San Diego, California, 92123, United States
Solutions Through Adv Rch /ID# 226104
Jacksonville, Florida, 32256, United States
Olympian Clinical Research- St. Petersburg /ID# 226106
St. Petersburg, Florida, 33709-1405, United States
Advanced Clinical Research Institute /ID# 248827
Tampa, Florida, 33607, United States
University Dermatology and Vein Clinic, LLC /ID# 226100
Darien, Illinois, 60561, United States
Arlington Dermatology /ID# 226097
Rolling Meadows, Illinois, 60008, United States
Skin Cancer and Dermatology Institute - Reno /ID# 248828
Reno, Nevada, 89509, United States
Univ Hosp Cleveland /ID# 248825
Cleveland, Ohio, 44106, United States
Apex Clinical Research Center /ID# 248830
Mayfield Heights, Ohio, 44124, United States
Medical University of South Carolina /ID# 248831
Charleston, South Carolina, 29425, United States
West Virginia University Hospitals /ID# 263438
Morgantown, West Virginia, 26506, United States
Wisconsin Medical Center /ID# 263437
Milwaukee, Wisconsin, 53226, United States
Karma Clinical Trials /ID# 233985
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Hospital for Sick Children /ID# 233986
Toronto, Ontario, M5G 1X8, Canada
Fachklinik Bad Bentheim /ID# 243904
Bad Bentheim, Lower Saxony, 48455, Germany
Universitaetsklinikum Bonn /ID# 243910
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Muenster /ID# 243905
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsmedizin Mainz /ID# 243907
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
Kiel, Schleswig-Holstein, 24105, Germany
Nagoya City University Hospital /ID# 248429
Nagoya, Aichi-ken, 467-8602, Japan
Mie University Hospital /ID# 263008
Tsu, Mie-ken, 514-8507, Japan
Kansai Medical University Hirakata Hospital /ID# 252332
Hirakata-shi, Osaka, 573-1191, Japan
Tokyo Medical University Hospital /ID# 252331
Shinjuku-ku, Tokyo, 160-0023, Japan
High-Med Przychodnia Specjalistyczna /ID# 243846
Warsaw, Masovian Voivodeship, 01-817, Poland
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 243847
Lodz, Łódź Voivodeship, 90-265, Poland
Dermoklinika Medical Center /ID# 243848
Lodz, Łódź Voivodeship, 90-436, Poland
Hospital Sant Joan de Deu /ID# 241103
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital General Universitario Gregorio Maranon /ID# 241099
Madrid, 28007, Spain
Hospital Universitario Infanta Leonor /ID# 241100
Madrid, 28031, Spain
Hospital Universitario 12 de Octubre /ID# 241102
Madrid, 28041, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 241101
Pontevedra, 36071, Spain
Royal Devon & Exeter Hospital /ID# 245101
Exeter, Devon, EX2 5DW, United Kingdom
Derriford Hospital and the Royal Eye Infirmary /ID# 245104
Plymouth, Devon, PL6 8DH, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100
London, Greater London, SE1 9RT, United Kingdom
Chelsea and Westminster Hospital /ID# 245102
London, Greater London, SW10 9NH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
April 27, 2021
Study Start
July 24, 2021
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.