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Monoclonal Antibodies

Ustekinumab for Pediatric Psoriatic Arthritis and Psoriasis (U-POPS Trial)

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>=5 to <18 years of age, inclusive, with a diagnosis of juvenile psoriatic arthritis (jPsA) by qualified HCP
>=6 to <18 years of age, inclusive, with a diagnosis of pediatric psoriasis (PsO) by a qualified HCP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing ustekinumab, a medication that controls the immune system, in children and adolescents with juvenile psoriatic arthritis and pediatric psoriasis. It works by blocking proteins that cause inflammation, aiming to reduce symptoms like swelling and pain. Ustekinumab has been shown to be effective in treating psoriasis and psoriatic arthritis.

Who is the study for?
This trial is for children and teens aged 6-18 with pediatric psoriasis, or ages 5-18 with juvenile psoriatic arthritis. They must have been treated with ustekinumab for at least 16 weeks and received three doses before joining. Participants need parental consent, and if old enough, they must also agree to join.
What is being tested?
The study focuses on understanding how the drug ustekinumab behaves in the bodies of young patients with juvenile psoriatic arthritis or pediatric psoriasis—specifically looking at its pharmacokinetics (how it's absorbed, distributed, metabolized, and excreted).
What are the potential side effects?
While not specified here, common side effects of ustekinumab may include respiratory infections like colds or sinus infections; headache; tiredness; itching; redness at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 6 and 17 years old and have been diagnosed with psoriasis by a qualified healthcare provider.
Select...
You have been taking ustekinumab for at least 16 weeks and have received at least 3 doses before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 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
Serum Concentration of Ustekinumab
Secondary study objectives
Number of Participants with Adverse Events (AEs)
Number of Participants with Antibodies to Ustekinumab
Number of Participants with Serious Adverse Events (SAEs)

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Skin and subcutaneous tissue disorders
9%
Fracture
9%
Anxiety
9%
Dizziness
9%
Back pain
9%
Urinary tract infection
5%
Toothache
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Pediatric Psoriasis (PsO)Experimental Treatment1 Intervention
Participants (aged \>=6 to \<18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP.
Group II: Cohort 1: Juvenile Psoriatic Arthritis (jPsA)Experimental Treatment1 Intervention
Participants (aged greater than or equal to \[\>=\] 5 to less than \[\<\] 18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating health care professional (HCP).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
2015
Completed Phase 4
~4080

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Psoriatic Arthritis (PsA) include biologic agents that target specific cytokines involved in the inflammatory process. Ustekinumab, for example, is a monoclonal antibody that targets IL-12 and IL-23, reducing inflammation and preventing joint damage. Other treatments may target IL-17 or TNF-alpha. These therapies are crucial for PsA patients as they help manage symptoms, improve physical function, and enhance quality of life by directly addressing the underlying inflammatory mechanisms of the disease.
Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials.Is ustekinumab effective for psoriatic arthritis with insufficient response to initial treatment?

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,401,016 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,979,117 Total Patients Enrolled

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05252533 — Phase 1
Juvenile Idiopathic Arthritis Research Study Groups: Cohort 1: Juvenile Psoriatic Arthritis (jPsA), Cohort 2: Pediatric Psoriasis (PsO)
Juvenile Idiopathic Arthritis Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT05252533 — Phase 1
Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05252533 — Phase 1
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