Risankizumab for Pediatric Psoriasis
(OptIMMize-2 Trial)

Recruiting in Palo Alto (17 mi)

+53 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for kids aged 6-17 with moderate to severe plaque psoriasis who finished study M19-977. They can join if they meet the new study's requirements but not if they had reasons to stop participating in the previous study.

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.

Treatment Details

Interventions

Risankizumab (Monoclonal Antibodies)

Trial OverviewThe trial tests Risankizumab, an adult psoriasis drug, in children. It involves getting shots every 12 weeks for nearly four years and checks how well it works and its safety through medical exams, blood tests, side effects monitoring, and questionnaires.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RisankizumabExperimental Treatment1 Intervention

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

Risankizumab is already approved in Canada, United States, European Union for the following indications:

🇨🇦 Approved in Canada as Skyrizi for: