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Monoclonal Antibodies

Ustekinumab/Guselkumab for Juvenile Psoriatic Arthritis (PSUMMIT-Jr Trial)

Phase 3
Recruiting
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
Active disease in at least >=3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12, 16, 24, and 52
Awards & highlights

PSUMMIT-Jr Trial Summary

This trial will compare the effects of two drugs on juvenile psoriatic arthritis.

Who is the study for?
This trial is for children with active juvenile psoriatic arthritis who've had it for at least 3 months. They must be up-to-date on immunizations and have tried other treatments without success. Kids can't join if they have a different type of arthritis, serious infections like TB, or hepatitis C.Check my eligibility
What is being tested?
The study tests Ustekinumab and Guselkumab's effects on juvenile psoriatic arthritis. It looks at how the body processes these drugs, their safety, effectiveness, and whether the body develops resistance to them.See study design
What are the potential side effects?
Possible side effects include reactions where the drug is injected, increased risk of infections due to immune system suppression, potential liver issues, and possibly others not yet known.

PSUMMIT-Jr Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have active arthritis in 3 or more joints.

PSUMMIT-Jr Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12, 16, 24, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12, 16, 24, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups
Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24
Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
+3 more
Secondary outcome measures
Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups
Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups
Cohorts 1 and 2: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS) 10 at Weeks 4, 8, 12, 16, 24, and 52
+12 more

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)

PSUMMIT-Jr Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: GuselkumabExperimental Treatment1 Intervention
The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.
Group II: Cohort 1: UstekinumabExperimental Treatment1 Intervention
Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Ustekinumab
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,269 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,866 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05083182 — Phase 3
Juvenile Arthritis Research Study Groups: Cohort 2: Guselkumab, Cohort 1: Ustekinumab
Juvenile Arthritis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05083182 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083182 — Phase 3

Frequently Asked Questions

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

What are the conditions that Ustekinumab is known to help with?

"Patients with adrenal cortex hormone deficiencies, an inadequate response to other TNF antagonist therapies, and psoriasis can be treated using Ustekinumab."

Answered by AI

Are new participants being sought for this experiment?

"Yes, this clinical trial is still recruiting patients as of today. The primary posting was on August 30th, 2020 but there have been updates as recently as November 9th, 2020."

Answered by AI

Where are patients able to access this trial?

"So far, 9 clinical sites have been established for this trial including Northwell Health in New york, Harvard Medical School - Boston Children's Hospital in Boston, and Childrens Hospital Los Angeles in Chapel Hill."

Answered by AI

Are there any known allergies or adverse effects to Ustekinumab?

"Ustekinumab's safety is estimated to be a 3. This assessment comes from the fact that it is a Phase 3 trial, meaning efficacy has been supported by some data and safety has been corroborated through multiple rounds of testing."

Answered by AI

How many people are subjects in this research?

"Yes, this is an ongoing clinical trial that has opened recruitment to the public. The first posting was on 8/30/2022 and the most recent update was on 11/9/2022. They are looking for a total of 60 patients from 9 different locations."

Answered by AI

Are there other ongoing research projects that are similar to this one involving Ustekinumab?

"35 different clinical trials are currently underway for Ustekinumab, 18 of which have progressed to Phase 3 testing. Out of the 2840 total locations running these trials, many are based in Gdansk, Pomorskie."

Answered by AI

Could I take part in this research if I qualify?

"This clinical trial is seeking 60 children and adolescents between the ages of 5-17 that have arthritis. Key inclusion criteria for candidates are as follows: A diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria, active disease in at least 3 joints, an inadequate response or intolerance to 1 non-steroidal anti-inflammatory drug (NSAID), an inadequate response or intolerance to 1 non-biological disease modifying anti-rheumatic drug (DMARD). If using corticosteroids, participants must be on a stable dose for 4 weeks before administration of study intervention. Lastly, if not currently using corticoster"

Answered by AI

If a patient is below 85 years old, are they still eligible for this program?

"This trial is for patients aged 5-17, which falls under the category of 'pediatric.' There are currently 70 active clinical trials involving pediatric patients and 363 research studies being conducted with elderly patients."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
2022. "A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05083182.
All > SJIA > Psoriatic Arthritis
~36 spots leftby Nov 2026
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