Risankizumab vs Adalimumab for Juvenile Psoriatic Arthritis

(KnaPsAck Trial)

Recruiting at 40 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Anti-TNF, IL-23 inhibitors

Disqualifiers: Other autoimmune diseases, Rheumatic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of risankizumab for treating juvenile psoriatic arthritis (jPsA), which causes joint pain and swelling in children. The study compares risankizumab, a new treatment under investigation, with adalimumab (Humira), already used for jPsA. Participants will be randomly assigned to one of these treatments. Eligible participants have jPsA affecting at least three joints and have not responded to other treatments like methotrexate or hydroxychloroquine. The trial involves regular hospital or clinic visits for check-ups and monitoring. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain medications, which might imply that you can continue with them if they are not effective. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found risankizumab to be safe for treating psoriatic arthritis. Common side effects, such as colds and headaches, affected at least 1% of patients and were usually easy to manage. Long-term research also showed that risankizumab safely improved joint and skin symptoms over time.

For adalimumab, already approved for juvenile psoriatic arthritis, serious infections were the main concern. However, these were rare, with low infection rates in children with similar conditions like juvenile idiopathic arthritis. Over time, adalimumab was well-tolerated and helped many patients significantly improve or even eliminate their symptoms.

Extensive studies have shown that both treatments are generally safe for most patients. Always consult a healthcare provider to understand the potential risks and benefits for your personal situation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about risankizumab for juvenile psoriatic arthritis because it targets a specific part of the immune system called interleukin-23 (IL-23), which plays a key role in inflammation. Unlike standard treatments like methotrexate or TNF inhibitors, risankizumab offers a different mechanism of action by focusing on IL-23 inhibition, potentially providing an alternative for patients who do not respond well to current therapies. Adalimumab, on the other hand, is a well-known TNF inhibitor that already serves as a standard treatment, but this trial aims to understand its efficacy specifically in juvenile cases compared to risankizumab. Researchers hope that these insights will lead to more personalized and effective treatment options for young patients suffering from this condition.

What evidence suggests that this trial's treatments could be effective for juvenile psoriatic arthritis?

This trial will compare risankizumab and adalimumab for juvenile psoriatic arthritis. Research has shown that both treatments effectively address psoriatic arthritis (PsA). Participants may receive risankizumab, which studies found led to 57% of patients experiencing noticeable improvement in joint symptoms after 24 weeks, with lasting effects. Alternatively, participants may receive adalimumab, already approved for PsA, which has significantly reduced disease activity and controlled joint damage. Both treatments have improved symptoms in PsA patients, making them promising options for juvenile psoriatic arthritis. ^{4 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have active disease in 3 or more joints.

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

I have been diagnosed with juvenile psoriatic arthritis for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants are randomized to receive risankizumab or adalimumab for 24 weeks

24 weeks

Regular visits at a hospital or clinic

Treatment Period 2

Participants who respond to the treatment in Period 1 continue the same treatment for another 100 weeks

100 weeks

Regular visits at a hospital or clinic

Follow-up for Adalimumab

Participants who receive adalimumab are followed for safety for 70 days after the last study treatment

10 weeks

Follow-up for Risankizumab

Participants who receive risankizumab are followed for safety for 140 days after the last study treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adalimumab
• Risankizumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Risankizumab Experimental Treatment 1 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: Adalimumab Experimental Treatment 1 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.

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in United States as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis
• Hidradenitis suppurativa

Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

In juvenile idiopathic arthritis (JIA) patients starting adalimumab therapy, anti-adalimumab antibody (AAA) production significantly increased starting at 3 months, with 34% of patients developing AAA by that time.

Risk factors for developing AAA included being female, having an elevated ESR, and using leflunomide, while the use of methotrexate was found to be protective against AAA development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-adalimumab antibodies kinetics: an early guide for juvenile idiopathic arthritis (JIA) switching. Brunelli, JB., Silva, CA., Pasoto, SG., et al.[2022]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

In the phase 3 KEEPsAKE 2 trial involving 444 patients with psoriatic arthritis, risankizumab significantly improved disease outcomes compared to placebo, with 51.3% of patients achieving at least a 20% improvement in their symptoms by week 24.

Risankizumab was well tolerated, with similar rates of serious adverse events (4.0% for risankizumab vs. 5.5% for placebo) and lower rates of serious infections compared to placebo, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Östör, A., Van den Bosch, F., Papp, K., et al.[2022]

In a 24-week study involving 356 patients with juvenile idiopathic arthritis (JIA), adalimumab demonstrated good safety, with an overall adverse drug reaction (ADR) rate of 29.8% and serious ADRs at 3.4%.

The effectiveness of adalimumab was notable, with the remission rate improving from 21.7% at baseline to 74.7% by week 24, indicating significant therapeutic benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study. Takei, S., Iwata, N., Kobayashi, I., et al.[2022]

Adalimumab demonstrated long-term safety and efficacy in treating juvenile idiopathic arthritis (JIA) over 6 years, with significant clinical responses observed in 66% to 96% of patients achieving various levels of improvement by week 104.

The treatment was well tolerated, with only 12 serious infections reported among 171 patients over 592.8 patient-years, and no severe adverse events like heart failure or malignancies, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate. Lovell, DJ., Brunner, HI., Reiff, AO., et al.[2021]

In a study involving 577 pediatric patients across various conditions, adalimumab was found to have a generally safe profile, with common adverse events including upper respiratory infections and headaches, but no new safety concerns were identified.

Serious infections occurred at a rate of 4.0 events per 100 patient-years, with pneumonia being the most frequent serious adverse event, indicating that while serious infections are a risk, they are relatively infrequent in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. Horneff, G., Seyger, MMB., Arikan, D., et al.[2019]

In a study involving 838 patients with polyarticular-course juvenile idiopathic arthritis, adalimumab (ADA) was found to be well tolerated, with no deaths or malignancies reported over a 7-year period.

Patients starting treatment with ADA ± methotrexate showed a trend towards lower disease activity compared to those on methotrexate alone, suggesting ADA may be more effective in managing symptoms in the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Brunner, HI., Nanda, K., Toth, M., et al.[2020]

Risankizumab is the first targeted interleukin-23 inhibitor approved for moderate-to-severe Crohn's disease, showing promising efficacy and a favorable safety profile in clinical trials involving both treatment-naïve and previously treated patients.

The specific mechanism of action of Risankizumab, which selectively inhibits IL-23, may offer enhanced efficacy and safety compared to broader IL-12/23 inhibitors, with ongoing trials exploring this potential advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab to treat moderately to severely active Crohn's disease in adults: an evaluation of trials and data. Johnson, AM., Loftus, EV.[2023]

Risankizumab is a monoclonal antibody that effectively targets IL-23, showing superior efficacy compared to placebo and other treatments like ustekinumab and adalimumab in pivotal phase III trials involving adults with moderate to severe plaque psoriasis.

In long-term studies, risankizumab demonstrated durable efficacy and improved quality of life for patients, with a favorable safety profile over more than 2.5 years of continuous treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis. Blair, HA.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12223267/

Effectiveness and Safety of Adalimumab Biosimilars in ...

PASI 75 and 90 responses at week 16 were achieved by a greater proportion of children and adolescents in the randomized clinical trial by Papp ...

2.

humirapro.com

humirapro.com/psoriatic-arthritis

HUMIRA® (adalimumab) for Psoriatic Arthritis (PsA)

Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from Adalimumab Effectiveness in Psoriatic Arthritis Trial. Arthritis Rheum.

3.

ped-rheum.biomedcentral.com

ped-rheum.biomedcentral.com/articles/10.1186/s12969-024-01046-3

Approaches and outcomes of adalimumab discontinuation in ...

The authors reported that 3 years after adalimumab discontinuation, ~ 80% of patients maintained LDA versus 95% in the adalimumab + methotrexate ...

4.

rmdopen.bmj.com

rmdopen.bmj.com/content/6/2/e001208

Long-term outcomes in patients with polyarticular juvenile ...

Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6923751/

Effectiveness of Adalimumab for the Treatment of Psoriatic ...

Adalimumab has been shown to be effective and reasonably safe in reducing disease activity and controlling joint damage in patients with PsA, even in comorbid ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3595151/

Adalimumab: long-term safety in 23 458 patients ...

The most frequently reported serious adverse events across indications were infections with greatest incidence in RA and CD trials.

7.

humirapro.com

humirapro.com/global-safety

HUMIRA® (adalimumab) Safety profile

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death.

8.

jpeds.com

jpeds.com/article/S0022-3476(18)30755-8/fulltext

Safety of Adalimumab in Pediatric Patients with ...

Serious infection rates were 2.7, 0.8, and 6.6 events/100 patient-years in patients with juvenile idiopathic arthritis, psoriasis, and Crohn's ...