Risankizumab + Lutikizumab for Psoriatic Arthritis

Recruiting at 6 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: HIV, Active HBV, Active HCV, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms. The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Risankizumab for Psoriatic Arthritis?

Research shows that Risankizumab, which targets a protein involved in inflammation, is effective in reducing joint swelling and tenderness, clearing skin plaques, and improving quality of life for people with psoriatic arthritis. It has been tested in several trials and is considered both safe and effective for this condition. ^{1 2 3 4 5}

Is the combination of Risankizumab and Lutikizumab safe for treating psoriatic arthritis?

Risankizumab has been shown to be generally safe in humans, with the most common side effect being upper respiratory tract infections. Serious adverse reactions reported include infections, cancer, and nervous system disorders, but these are rare. No specific safety data for Lutikizumab in combination with Risankizumab is available. ^{2 5 6 7 8}

How is the drug Risankizumab + Lutikizumab unique for treating psoriatic arthritis?

Risankizumab is unique because it targets the p19 subunit of interleukin-23, a protein involved in the immune response that contributes to psoriatic arthritis. This makes it different from other treatments that may target different parts of the immune system. Lutikizumab's role in this combination is not detailed, but the combination could offer a novel approach by potentially addressing multiple pathways involved in the disease. ^{2 5 9 10 11}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with active psoriatic arthritis who have at least 3 tender and swollen joints, a diagnosis of PsA for over 6 months, and meet specific criteria. They must have tried 1-2 targeted therapies without success. Excluded are those with recent major surgery, chronic infections like HIV or hepatitis, other skin diseases that could affect assessments, or different inflammatory joint diseases.

Inclusion Criteria

Participant is willing and able to comply with procedures required in the Master Protocol and substudies

I have at least 3 tender and 3 swollen joints.

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

Exclusion Criteria

I haven't had major surgery in the last 12 weeks and don't plan any during the study.

I do not have HIV, active hepatitis B or C, or active tuberculosis.

I have no skin conditions affecting my psoriasis evaluation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lutikizumab monotherapy, risankizumab monotherapy, or a combination therapy of lutikizumab and risankizumab. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

16 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events.

Up to 36 weeks

Treatment Details

Interventions

• Lutikizumab
• Risankizumab

Trial Overview The trial is testing Risankizumab and Lutikizumab alone or in combination to treat psoriatic arthritis. Participants will be randomly assigned to one of three treatment groups in equal numbers across approximately 40 global sites. The study involves regular hospital visits for medical checks, blood tests, side effect monitoring, and questionnaires.

Participant Groups

Group I: SubStudy 1: Lutikizumab and Risankizumab Combination Therapy Experimental Treatment 2 Interventions

Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.

Group II: Sub-Study 1: Risankizumab Monotherapy Experimental Treatment 1 Intervention

Participants will receive Risankizumab

Group III: Sub-Study 1: Lutikizumab Monotherapy Experimental Treatment 1 Intervention

Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.

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

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, an anti-IL23 monoclonal antibody, demonstrated linear pharmacokinetics in patients with active psoriatic arthritis (PsA), with a favorable safety profile and robust efficacy when administered at a regimen of 150 mg subcutaneously at weeks 0, 4, and every 12 weeks thereafter.

The study analyzed data from 1527 participants across multiple clinical trials, confirming that the pharmacokinetics of risankizumab in PsA are comparable to those in patients with plaque psoriasis, with no significant impact of covariates on drug exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Thakre, N., D'Cunha, R., Goebel, A., 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]

References

1. 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]

2. 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]

3. Australia pubmed.ncbi.nlm.nih.gov

Novel combination biologic therapy for recalcitrant psoriasis and psoriatic arthritis in a medically complex patient. [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. Canada pubmed.ncbi.nlm.nih.gov

Risankizumab in Adults with Psoriatic Arthritis. [2023]

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

Efficacy and safety of Risankizumab in moderate to severe psoriasis: A systematic review and meta-analysis. [2021]

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

Risankizumab for the treatment of moderate-to-severe psoriasis: A multicenter, retrospective, 1 year real-life study. [2022]

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. England pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. [2022]

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

Risankizumab: First Global Approval. [2020]