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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

U-POPS Trial Summary

This trial looks at how well ustekinumab works in children with psoriatic arthritis or psoriasis.

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.Check my eligibility
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).See study design
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.

U-POPS Trial 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.

U-POPS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum Concentration of Ustekinumab
Secondary outcome measures
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%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

U-POPS 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
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,277 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,874 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05252533 — Phase 1
Psoriatic Arthritis Research Study Groups: Cohort 1: Juvenile Psoriatic Arthritis (jPsA), Cohort 2: Pediatric Psoriasis (PsO)
Psoriatic 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

Frequently Asked Questions

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

How many participants are being welcomed into this clinical research endeavor?

"To complete the research objectives of this trial, a total of 75 appropriate patients need to be enrolled. Janssen Research & Development LLC is managing recruitment out of several sites including Medical University of South carolina in Charleston and Dell Children's Medical Center of Central Texas in Austin."

Answered by AI

Where are the majority of locations conducting this trial occurring within the state?

"The Medical University of South carolina, Dell Children's Medical Center of Central Texas and Cincinnati Children's Hospital Medical Centre are amongst the 8 clinical trial sites running this study. All locations can be found in Charleston (South Caroline), Austin (Texas) and Cincinnati (California)."

Answered by AI

Has Ustekinumab been granted regulatory clearance by the FDA?

"Our team assigned a rating of 1 to ustekinumab due to the Phase 1 trial status and therefore, limited information available attesting to its safety or efficacy."

Answered by AI

Who is the ideal demographic for taking part in this investigation?

"This trial is recruiting 75 minors aged 5-17 afflicted with juvenile psoriatic arthritis (jPsA). The eligibility criteria are: age between 5 and 18 years old, receiving ustekinumab treatment for at least 16 weeks prior to enrollment, 3 or more doses of ustekinumab before taking part in the research. Additionally, children must have pediatric psoriasis (PsO) diagnosed by a qualified health professional and provide their parents' informed consent. For those capable of understanding the experiment's purpose (7 years old or older), assent will also be required as detailed in the ICF process."

Answered by AI

Are any individuals who are 45 years or older being included in this investigation?

"The parameters for eligibility state that children aged 5-17 may join the trial."

Answered by AI

Are there still open slots available to volunteers for this experiment?

"The research team is actively seeking participants, as evidenced by the clinicaltrials.gov data which indicates that this medical study was posted on May 24th 2022 and lastly updated on November 9th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
2022. "A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05252533.
~11 spots leftby Apr 2025
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