OptIMMize-2: 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

Sponsor

AbbVie (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04862286

Collaborator

(none)

132

Enrollment

Locations

Arm

99.7

Anticipated Duration (Months)

6.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Risankizumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jul 24, 2021

Anticipated Primary Completion Date :

Nov 15, 2029

Anticipated Study Completion Date :

Nov 15, 2029

Arms and Interventions

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: ABBV-066 BI 655066 SKYRIZI risankizumab-rzaa

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:

ABBV-066

BI 655066

SKYRIZI

risankizumab-rzaa

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First OC Dermatology /ID# 226942	Fountain Valley	California	United States	92708-3701
2	Integrative Skin Science and Research /ID# 226108	Sacramento	California	United States	95815-4500
3	Solutions Through Adv Rch /ID# 226104	Jacksonville	Florida	United States	32256
4	Olympian Clinical Research - Largo /ID# 226106	Largo	Florida	United States	33770
5	University Dermatology and Vein Clinic, LLC /ID# 226100	Darien	Illinois	United States	60561
6	Arlington Dermatology /ID# 226097	Rolling Meadows	Illinois	United States	60008
7	Universitaetsklinikum Muenster /ID# 243905	Muenster	Nordrhein-Westfalen	Germany	48149
8	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883	Kiel	Schleswig-Holstein	Germany	24105
9	Fachklinik Bad Bentheim /ID# 243904	Bad Bentheim		Germany	48455
10	Universitaetsklinikum Bonn /ID# 243910	Bonn		Germany	53127
11	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 243908	Dresden		Germany	01307
12	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 243907	Mainz		Germany	55131
13	Dermoklinika Medical Center /ID# 243848	Lodz	Lodzkie	Poland	90-436
14	KSW nr1 w Rzeszowie /ID# 243850	Rzeszow	Podkarpackie	Poland	35-055
15	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849	Gdansk	Pomorskie	Poland	80-546
16	Hospital Sant Joan de Deu /ID# 241103	Esplugues de Llobregat	Barcelona	Spain	08950
17	Hospital General Universitario Gregorio Maranon /ID# 241099	Madrid		Spain	28007
18	Hospital Universitario Infanta Leonor /ID# 241100	Madrid		Spain	28031
19	Hospital Universitario 12 de Octubre /ID# 241102	Madrid		Spain	28041
20	Complejo Hospitalario Universitario de Pontevedra /ID# 241101	Pontevedra		Spain	36071