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Monoclonal Antibodies

Risankizumab for Pediatric Psoriasis (OptIMMize-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 224 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will evaluate the safety and efficacy of risankizumab in pediatric participants with moderate to severe plaque psoriasis.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of Risankizumab include reactions at the injection site, infections due to immune system suppression, headaches, fatigue, digestive issues and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 224 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 224 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475
14%
COVID-19
8%
NASOPHARYNGITIS
4%
HEADACHE
3%
NAUSEA
3%
UPPER RESPIRATORY TRACT INFECTION
1%
DIARRHOEA
1%
CORONARY ARTERY DISEASE
1%
PROSTATE CANCER
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period B: APR/APR
Period A: APR
Period A: RZB
Period B: RZB/RZB
Period B: APR/RZB
Period B: APR/APR/RZB

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RisankizumabExperimental Treatment1 Intervention
Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 4
~3340

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,182 Total Patients Enrolled
62 Trials studying Psoriasis
125,491 Patients Enrolled for Psoriasis
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,668 Total Patients Enrolled
22 Trials studying Psoriasis
17,942 Patients Enrolled for Psoriasis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04862286 — Phase 3
~73 spots leftby Feb 2029
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