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

Psoriasis Clinical Trial

— 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04862286
• Other study ID #: M19-973
• Secondary ID: 2022-500408-22-0
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: July 24, 2021
• Est. completion date: November 15, 2029

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 132
• Est. completion date: November 15, 2029
• Est. primary completion date: November 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Subcutaneous (SC) injection.

Locations

Country	Name	City	State
Canada	Dermatology Research Institute Inc. /ID# 233988	Calgary	Alberta
Canada	CHU Sainte-Justine /ID# 233987	Montreal	Quebec
Canada	Karma Clinical Trials /ID# 233985	St. John's	Newfoundland and Labrador
Canada	Hospital for Sick Children /ID# 233986	Toronto	Ontario
Germany	Fachklinik Bad Bentheim /ID# 243904	Bad Bentheim
Germany	Universitaetsklinikum Bonn /ID# 243910	Bonn
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908	Dresden
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883	Kiel	Schleswig-Holstein
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907	Mainz
Germany	Universitaetsklinikum Muenster /ID# 243905	Muenster	Nordrhein-Westfalen
Japan	Nagoya City University Hospital /ID# 248429	Nagoya shi	Aichi
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849	Gdansk	Pomorskie
Poland	Dermed Centrum Medyczne Sp. z o.o /ID# 243847	Lodz	Lodzkie
Poland	Dermoklinika Medical Center /ID# 243848	Lodz	Lodzkie
Poland	KSW nr1 w Rzeszowie /ID# 243850	Rzeszow	Podkarpackie
Poland	High-Med Przychodnia Specjalistyczna /ID# 243846	Warszawa	Mazowieckie
Spain	Hospital Sant Joan de Deu /ID# 241103	Esplugues de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Maranon /ID# 241099	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 241102	Madrid
Spain	Hospital Universitario Infanta Leonor /ID# 241100	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 241101	Pontevedra
United Kingdom	Frimley Health NHS Foundation Trust /ID# 245105	Camberley
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust /ID# 245101	Exeter	Devon
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust /ID# 245102	London
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 245100	London	London, City Of
United Kingdom	University Hospital Plymouth NHS Trust /ID# 245104	Plymouth
United States	Medical University of South Carolina /ID# 248831	Charleston	South Carolina
United States	Univ Hosp Cleveland /ID# 248825	Cleveland	Ohio
United States	University Dermatology and Vein Clinic, LLC /ID# 226100	Darien	Illinois
United States	First OC Dermatology /ID# 226942	Fountain Valley	California
United States	Solutions Through Adv Rch /ID# 226104	Jacksonville	Florida
United States	Apex Dermatology & Skin Surgery Center /ID# 248830	Mayfield Heights	Ohio
United States	Skin Cancer and Dermatology Institute (SCDI) /ID# 248828	Reno	Nevada
United States	Arlington Dermatology /ID# 226097	Rolling Meadows	Illinois
United States	Integrative Skin Science and Research /ID# 226108	Sacramento	California
United States	Olympian Clinical Research- St. Petersburg /ID# 226106	Saint Petersburg	Florida
United States	Advanced Clinical Research Institute /ID# 248827	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Japan,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.