What is the mechanism of action of this treatment?

Psoriatic Arthritis (PsA) treatments often target specific immune pathways to reduce inflammation and disease activity. Risankizumab, an IL-23 inhibitor, works by blocking the IL-23 protein, which reduces the activation of Th17 cells and subsequent inflammation. Adalimumab, a TNF inhibitor, reduces inflammation by blocking TNF, a cytokine involved in systemic inflammation. These treatments are crucial for PsA patients as they help in managing symptoms and preventing disease progression by targeting the underlying immune mechanisms.

What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis include IL-23 inhibitors like Risankizumab and TNF-alpha inhibitors like Adalimumab. IL-23 inhibitors are generally well-tolerated but can cause side effects such as upper respiratory infections, headache, fatigue, and injection site reactions. TNF-alpha inhibitors, while effective, may lead to increased risk of infections, injection site reactions, and potential cardiovascular benefits. Both classes of drugs require monitoring for serious infections and other adverse effects.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Psoriatic Arthritis, including IL-23 inhibitors like Risankizumab. Ustekinumab, which targets IL-12/23, is another approved treatment for PsA. Additionally, TNF inhibitors such as Adalimumab and IL-17 inhibitors like Secukinumab and Ixekizumab have been approved for PsA. These biologics work by modulating the immune system to reduce inflammation and disease activity in PsA patients.

What other types of research exist?

Promising novel alternatives to Risankizumab for Psoriatic Arthritis patients include: 1) Secukinumab (IL-17A inhibition), which has shown significant improvement in joint and skin symptoms and is well-tolerated. 2) Ixekizumab (IL-17A inhibition), which has demonstrated efficacy in both plaque psoriasis and PsA. 3) Guselkumab (IL-23 inhibition), which has shown efficacy in generalized pustular psoriasis and erythrodermic psoriasis, indicating potential for PsA. 4) Bimekizumab (dual IL-17A and IL-17F inhibition), which has shown promising results in plaque psoriasis and PsA.

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Monoclonal Antibodies

Risankizumab vs Adalimumab for Juvenile Psoriatic Arthritis (KnaPsAck Trial)

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active Disease in >= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.

Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying the safety and effectiveness of a medication called risankizumab for the treatment of psoriatic arthritis in children. Psoriatic arthritis is a type of arthritis that causes joint

Who is the study for?

This trial is for children with juvenile Psoriatic Arthritis (jPsA) who have had it for at least 6 months, are experiencing active disease in three or more joints, and haven't responded well to treatments like methotrexate. Kids can't join if they meet certain medical conditions that the study outlines.

What is being tested?

The trial is testing Risankizumab against Adalimumab, both given as injections based on body weight. Participants will be randomly assigned to one of these drugs for an initial period of 24 weeks and may continue up to another 100 weeks depending on their response.

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, nausea, and potential allergic reactions. Long-term effects are monitored over several months.

Eligibility Criteria

Inclusion Criteria

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

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I have active disease in 3 or more joints.

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My previous treatment for at least 2 months did not work.

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I cannot tolerate one of the common arthritis medications like methotrexate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)

Secondary study objectives

Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10

Change from Baseline in JADAS-27

Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10

+11 more

Awards & Highlights

Pivotal Trial

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

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: RisankizumabExperimental Treatment1 Intervention

Participants will receive risankizumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 140 day safety follow up after the treatment period.

Group II: AdalimumabExperimental Treatment1 Intervention

Participants will receive adalimumab for 24 weeks, in Period 1. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. There will be a 70 day safety follow up after the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adalimumab

2013

Completed Phase 4

~7950

Risankizumab

2021

Completed Phase 4

~3340

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

Psoriatic Arthritis (PsA) treatments often target specific immune pathways to reduce inflammation and disease activity. Risankizumab, an IL-23 inhibitor, works by blocking the IL-23 protein, which reduces the activation of Th17 cells and subsequent inflammation. Adalimumab, a TNF inhibitor, reduces inflammation by blocking TNF, a cytokine involved in systemic inflammation. These treatments are crucial for PsA patients as they help in managing symptoms and preventing disease progression by targeting the underlying immune mechanisms.

Palmoplantar Psoriasis Successfully Treated With Risankizumab.