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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

Must not have

Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening

Have a history of, or ongoing, chronic or recurrent infectious disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 8, 12, 16, 24, and 52

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have active arthritis in 3 or more joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had TB or fungal infections like histoplasmosis or coccidioidomycosis.

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I have a history of or currently have a chronic infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8, 12, 16, 24, and 52

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~6080

Ustekinumab

2015