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)

August 7, 2025 updated by: AbbVie

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)

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 233985
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children /ID# 233986
  • Germany
    • Niedersachsen
      • Bad Bentheim, Niedersachsen, Germany, 48455
        • Fachklinik Bad Bentheim /ID# 243904
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 243910
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 243905
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitaetsmedizin Mainz /ID# 243907
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
  • Japan
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 248429
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital /ID# 263008
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hirakata Hospital /ID# 252332
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 252331
  • Poland
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-265
        • Dermed Centrum Medyczne Sp. z o.o /ID# 243847
      • Lodz, Lodzkie, Poland, 90-436
        • Dermoklinika Medical Center /ID# 243848
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-817
        • High-Med Przychodnia Specjalistyczna /ID# 243846
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 241099
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor /ID# 241100
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 241102
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario Universitario de Pontevedra /ID# 241101
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Deu /ID# 241103
  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital /ID# 245101
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital and the Royal Eye Infirmary /ID# 245104
    • Greater London
      • London, Greater London, United Kingdom, SE1 9RT
        • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100
      • London, Greater London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital /ID# 245102
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Department of Dermatology /ID# 252305
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology /ID# 226942
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research /ID# 226108
      • San Diego, California, United States, 92123
        • University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Solutions Through Adv Rch /ID# 226104
      • Saint Petersburg, Florida, United States, 33709-1405
        • Olympian Clinical Research- St. Petersburg /ID# 226106
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute /ID# 248827
    • Illinois
      • Darien, Illinois, United States, 60561
        • University Dermatology and Vein Clinic, LLC /ID# 226100
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology /ID# 226097
    • Nevada
      • Reno, Nevada, United States, 89509
        • Skin Cancer and Dermatology Institute - Reno /ID# 248828
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp Cleveland /ID# 248825
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center /ID# 248830
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 248831
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals /ID# 263438
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Wisconsin Medical Center /ID# 263437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

--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.

Exclusion Criteria:

--Participants who have developed any discontinuation criteria as defined in Study M19-977.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risankizumab
Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
Drug: Risankizumab
Subcutaneous (SC) injection.
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI
  • risankizumab-rzaa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Up to approximately 224 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2021

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-973
  • 2022-500408-22-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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