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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

OptIMMize-2 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.Check my eligibility
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.See study design
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.

OptIMMize-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events

Side effects data

From 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

OptIMMize-2 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 3
~3140

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
496,340 Total Patients Enrolled
61 Trials studying Psoriasis
125,144 Patients Enrolled for Psoriasis
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,021 Total Patients Enrolled
21 Trials studying Psoriasis
17,595 Patients Enrolled for Psoriasis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04862286 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient is below the age of 40, can they be still be included in this experiment?

"This study includes children that are at least 6 years old but no older than 17."

Answered by AI

How many different facilities are coordinating this trial?

"SCDI /ID# 248828 in Reno, Apex Dermatology & Skin Surgery Center /ID# 248830 in Mayfield Heights, and Univ Hosp Cleveland /ID# 248825 in Cleveland are a few of the 18 locations that are taking part in this trial."

Answered by AI

Could I possibly take part in this research project?

"As this is a children's study, only young patients aged 6 to 17 who have psoriasis are applicable. In total, the research team needs to recruit 132 participants."

Answered by AI

Are patients being enrolled in this research project at present?

"Unfortunately, this specific trial is not currently looking for patients to enroll. Although the 208 other trials might be of interest, they are not related. This particular study was originally posted on 7/24/2021 and was last updated on 11/9/2022 according to clinicaltrials.gov"

Answered by AI

What are common indications for Risankizumab?

"Risankizumab is not just limited to treating dental plaque, but can also be used for patients with psoriasis, skin disinfection therapy, and psoriatic arthritis."

Answered by AI

What is the experimental history of Risankizumab?

"As of now, there are 29 clinical trials underway for Risankizumab. Out of those, 14 are in their third and final phase. Although the majority of these studies originate from Gdansk, Pomorskie, there are 3206 total research sites conducting these experiments."

Answered by AI

How many people are currently signed up for this research project?

"As of right now, this clinical trial is not searching for any more participants. According to the most recent update on November 9th, 2022, this study was first posted on July 24th, 2021. There are a total of 179 trials involving psoriasis patients and 29 trials concerning Risankizumab that are actively recruiting individuals as we speak."

Answered by AI

Are there any serious side effects associated with Risankizumab?

"Phase 3 trials have collected data supporting efficacy and safety, so Risankizumab was given a score of 3 for safety."

Answered by AI
~88 spots leftby Nov 2029