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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)

Primary Purpose

Psoriasis

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis, Risankizumab, SKYRIZI, ABBV-066, BI 655066, Risankizumab-rzaa

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First OC Dermatology /ID# 226942
  • Integrative Skin Science and Research /ID# 226108
  • Solutions Through Adv Rch /ID# 226104
  • Olympian Clinical Research- St. Petersburg /ID# 226106
  • Advanced Clinical Research Institute /ID# 248827
  • University Dermatology and Vein Clinic, LLC /ID# 226100
  • Arlington Dermatology /ID# 226097
  • Skin Cancer and Dermatology Institute (SCDI) /ID# 248828
  • Univ Hosp Cleveland /ID# 248825
  • Apex Dermatology & Skin Surgery Center /ID# 248830
  • Medical University of South Carolina /ID# 248831
  • Dermatology Research Institute Inc. /ID# 233988
  • Karma Clinical Trials /ID# 233985
  • Hospital for Sick Children /ID# 233986
  • CHU Sainte-Justine /ID# 233987
  • Universitaetsklinikum Muenster /ID# 243905
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
  • Fachklinik Bad Bentheim /ID# 243904
  • Universitaetsklinikum Bonn /ID# 243910
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907
  • Nagoya City University Hospital /ID# 248429
  • Dermed Centrum Medyczne Sp. z o.o /ID# 243847
  • Dermoklinika Medical Center /ID# 243848
  • High-Med Przychodnia Specjalistyczna /ID# 243846
  • KSW nr1 w Rzeszowie /ID# 243850
  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
  • Hospital Sant Joan de Deu /ID# 241103
  • Hospital General Universitario Gregorio Maranon /ID# 241099
  • Hospital Universitario Infanta Leonor /ID# 241100
  • Hospital Universitario 12 de Octubre /ID# 241102
  • Complejo Hospitalario Universitario de Pontevedra /ID# 241101
  • Royal Devon University Healthcare NHS Foundation Trust /ID# 245101
  • Guys and St Thomas NHS Foundation Trust /ID# 245100
  • Frimley Health NHS Foundation Trust /ID# 245105
  • Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102
  • University Hospital Plymouth NHS Trust /ID# 245104

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risankizumab

Arm Description

Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2021
Last Updated
February 9, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04862286
Brief Title
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
Acronym
OptIMMize-2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
November 15, 2029 (Anticipated)
Study Completion Date
November 15, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Psoriasis, Risankizumab, SKYRIZI, ABBV-066, BI 655066, Risankizumab-rzaa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI, risankizumab-rzaa
Intervention Description
Subcutaneous (SC) injection.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Up to approximately 224 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
First OC Dermatology /ID# 226942
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Facility Name
Integrative Skin Science and Research /ID# 226108
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4500
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 226104
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Olympian Clinical Research- St. Petersburg /ID# 226106
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-1405
Country
United States
Facility Name
Advanced Clinical Research Institute /ID# 248827
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6429
Country
United States
Facility Name
University Dermatology and Vein Clinic, LLC /ID# 226100
City
Darien
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
Arlington Dermatology /ID# 226097
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Skin Cancer and Dermatology Institute (SCDI) /ID# 248828
City
Reno
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 248825
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Apex Dermatology & Skin Surgery Center /ID# 248830
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124-6509
Country
United States
Facility Name
Medical University of South Carolina /ID# 248831
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Dermatology Research Institute Inc. /ID# 233988
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Karma Clinical Trials /ID# 233985
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
Hospital for Sick Children /ID# 233986
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
CHU Sainte-Justine /ID# 233987
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Universitaetsklinikum Muenster /ID# 243905
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Fachklinik Bad Bentheim /ID# 243904
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Universitaetsklinikum Bonn /ID# 243910
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Nagoya City University Hospital /ID# 248429
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 243847
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Dermoklinika Medical Center /ID# 243848
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Facility Name
High-Med Przychodnia Specjalistyczna /ID# 243846
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-817
Country
Poland
Facility Name
KSW nr1 w Rzeszowie /ID# 243850
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Hospital Sant Joan de Deu /ID# 241103
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 241099
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor /ID# 241100
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 241102
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 241101
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Royal Devon University Healthcare NHS Foundation Trust /ID# 245101
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 245100
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Frimley Health NHS Foundation Trust /ID# 245105
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
University Hospital Plymouth NHS Trust /ID# 245104
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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

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