Risankizumab for Psoriatic Arthritis

(KEEPsAKE 1 Trial)

Not currently recruiting at 312 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Biologic agents

Disqualifiers: Hypersensitivity to risankizumab, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 152

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of risankizumab for individuals with psoriatic arthritis, a type of arthritis often accompanied by skin issues like psoriasis. The study compares risankizumab to a placebo to determine its impact on reducing joint pain and swelling. Suitable participants have experienced psoriatic arthritis symptoms for six months or more, have active joint pain and swelling, and have not responded well to other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have an inadequate response or intolerance to certain arthritis drugs, which might imply some changes to your medication. Please consult with the trial team for specific guidance.

Is there any evidence suggesting that risankizumab is likely to be safe for humans?

Research has shown that risankizumab is generally safe for treating psoriatic diseases. Long-term studies have not identified any new safety issues with this treatment. Common side effects include colds, headaches, fatigue, and reactions at the injection site, occurring in more than 1% of patients. Overall, the treatment is considered well-tolerated, with most side effects being mild to moderate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Unlike the standard treatments for psoriatic arthritis, such as methotrexate and TNF inhibitors, risankizumab works by specifically targeting interleukin-23 (IL-23), a key protein in the inflammatory process. This targeted approach aims to reduce inflammation more precisely, potentially leading to fewer side effects compared to broader immune suppressants. Researchers are excited about risankizumab because it offers a novel mechanism of action that could provide better symptom control for patients who do not respond well to existing therapies. Additionally, the convenience of a subcutaneous injection every 12 weeks after the initial dosing phase is a significant advantage, making it easier for patients to manage their treatment.

What evidence suggests that risankizumab might be an effective treatment for psoriatic arthritis?

Research has shown that risankizumab, which participants in this trial may receive, can help treat psoriatic arthritis (PsA). One study found that 57% of patients experienced a 20% improvement in joint pain and swelling after 24 weeks, compared to only 26.5% of those who took a placebo. Another study reported that 71.3% of participants had major improvements in psoriasis symptoms, such as skin lesions, with risankizumab. These findings suggest that risankizumab may help reduce both joint and skin symptoms in people with PsA. ^{4 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people with active Psoriatic Arthritis who haven't responded well to or can't tolerate at least one standard anti-rheumatic drug. They should have had symptoms for over 6 months, meet specific criteria including certain blood protein levels or skin/nail psoriasis signs, and have joint inflammation.

Inclusion Criteria

I have been diagnosed with Psoriatic Arthritis for at least 6 months.

You have at least one erosion on a radiograph as checked by a central imaging review.

Your high sensitivity C-reactive protein (hsCRP) level is higher than 3.0 mg/L.

Exclusion Criteria

I have been treated with a biologic agent before.

Participant has a known hypersensitivity to risankizumab.

Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Period 1

Randomized, double-blind, placebo-controlled treatment with risankizumab or placebo

24 weeks

Visits at Week 0, Week 4, and Week 16

Treatment Period 2

Long-term open-label treatment with risankizumab every 12 weeks

292 weeks

Visits every 12 weeks until Week 316

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Telephone call 140 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Risankizumab

Trial Overview The study is testing the effectiveness of Risankizumab compared to a placebo in treating Psoriatic Arthritis. Participants will be randomly assigned to receive either the actual medication or a placebo without knowing which one they are getting.

How Is the Trial Designed?

Group I: Risankizumab Experimental Treatment 2 Interventions

Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Group II: Placebo Placebo Group 2 Interventions

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

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

Approved in Canada as Skyrizi for:

• Moderate-to-severe Crohn's disease

Approved in United States as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis

Approved in European Union as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis
• Psoriatic 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

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 Phase 3 trial involving patients with psoriatic arthritis who had inadequate responses to previous treatments, risankizumab (RZB) significantly improved patient-reported outcomes, including pain, fatigue, and overall health-related quality of life compared to placebo.

Patients treated with RZB reported better scores in multiple health assessments, including the SF-36 and FACIT-Fatigue, indicating enhanced ability to perform daily activities and work, demonstrating its efficacy in managing symptoms of psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. Ostor, AJK., Soliman, AM., Papp, KA., et al.[2022]

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]

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]

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. skyrizi.com skyrizi.com/psoriatic-arthritis/skyrizi-results/efficacy

SKYRIZI® (risankizumab-rzaa) Results for Psoriatic Arthritis The majority of patients felt a 20% improvement and significant relief in PsA symptoms, including joint pain, stiffness and swelling at 24 weeks.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10234194/

Efficacy and safety of risankizumab for active psoriatic ... In the 24-week primary analysis, 51.3% of patients who received risankizumab achieved ≥20% improvement in ACR criteria (ACR20) compared with 26.5% of patients ...

3. skyrizihcp.com skyrizihcp.com/dermatology/psoriatic-arthritis-efficacy

SKYRIZI® Efficacy in Active Psoriatic Arthritis (PsA) After 3 doses of SKYRIZI, 57% of patients achieved ACR20 response at week 24 VS placebo. In patients who achieved PASI 90 at Week 16, 88% maintained PASI 90 at ...

4. rheumatologyadvisor.com rheumatologyadvisor.com/news/risankizumab-shows-sustained-efficacy-across-grappa-psa-domains/

Risankizumab Shows Sustained Efficacy Across Psoriatic ... In the KEEPsAKE 1 trial, 71.3% of participants achieved an at least 90% improvement in Psoriasis Area and Severity Index (PASI) scores and 72.7% ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/11/3/e005522

Efficacy of risankizumab across GRAPPA domains in ... Risankizumab demonstrated efficacy across all GRAPPA-defined domains through 100 weeks, including swollen and tender joint counts, enthesitis, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393270/

Long-Term Safety of Risankizumab in Patients with ... The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns.

7. skyrizihcp.com skyrizihcp.com/dermatology/pso-psa-safety-profile

SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1 Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41028616/

Efficacy and Safety of Risankizumab for Active Psoriatic ... Maintenance of ACR20 achievement in KS1 from week 52 to week 196 was observed for 71.0% of patients receiving continuous risankizumab and 72.7% ...

9. academic.oup.com academic.oup.com/rheumatology/article/62/6/2122/6772503

Efficacy and safety of risankizumab for active psoriatic arthritis ... In the 24-week primary analysis, 51.3% of patients who received risankizumab achieved ≥20% improvement in ACR criteria (ACR20) compared with 26.5% of patients ...