Risankizumab for Psoriatic Arthritis

(KEEPsAKE 1 Trial)

Recruiting at 268 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

964 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

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.

What data supports the effectiveness of the drug Risankizumab for treating psoriatic arthritis?

Research shows that Risankizumab, a drug that targets a specific part of the immune system, has been effective in improving symptoms for people with psoriatic arthritis, especially those who did not respond well to other treatments. Clinical trials, like KEEPsAKE 1 and 2, have demonstrated its ability to improve patient-reported outcomes and manage the condition over time. ^{1 2 3 4 5}

What is the safety profile of Risankizumab for Psoriatic Arthritis?

Risankizumab has been studied for safety in conditions like psoriasis and psoriatic arthritis, with some serious side effects reported, including infections, cancer, and heart issues. However, these findings are based on real-world data and clinical trials, and while they confirm the known safety profile, further investigation into certain adverse reactions is encouraged. ^{1 2 3 6 7}

How is the drug Risankizumab unique for treating psoriatic arthritis?

Risankizumab is unique because it specifically targets the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation, which is different from many other treatments that target different pathways. This makes it a novel option for patients who have not responded well to other biological therapies or conventional treatments. ^{1 2 8 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. [2022]

4. England 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. [2022]

5. England 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 1 trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of Risankizumab in the Treatment of Psoriasis and Arthritic Psoriasis: Real-World Data from EudraVigilance Database. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis. [2020]

9. England 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. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

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