What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis, such as Ustekinumab (targeting IL-12 and IL-23), Secukinumab, and Ixekizumab (both targeting IL-17), have several known side effects. These include an increased risk of infections, injection-site reactions, and potential psychological disorders. Ustekinumab specifically has been associated with a high risk of cancer development during prolonged treatment, as observed in animal studies. Other side effects across these treatments can include serious infections, such as tuberculosis, and cardiovascular events like myocardial infarctions and strokes. Patients should discuss these risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Ustekinumab, a monoclonal antibody targeting IL-12 and IL-23, has been FDA-approved for the treatment of Psoriatic Arthritis. Other similar biologic agents include secukinumab and ixekizumab, which target IL-17A, and brodalumab, another IL-17 inhibitor. Additionally, TNF inhibitors like adalimumab and etanercept have been widely used for PsA. These biologics work by reducing inflammation and halting disease progression, offering significant clinical benefits for patients with PsA.

What other types of research exist?

Promising alternatives to Ustekinumab for Psoriatic Arthritis patients include Secukinumab and Ixekizumab, both of which are IL-17 inhibitors. Secukinumab has shown significant improvement in joint and skin symptoms, physical function, and quality of life, with sustained benefits and a favorable safety profile. Ixekizumab has also demonstrated efficacy in treating PsA, particularly in patients with moderate-to-severe plaque psoriasis.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 weeks

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

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Rash/Rash Acneiform/Maculo-Papular

Toothache

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.

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

0 / 3Eligibility criteria met

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?