Risankizumab + Lutikizumab for Psoriatic Arthritis

Recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two new treatments, risankizumab and lutikizumab, for individuals with psoriatic arthritis—a condition where the immune system mistakenly attacks joints, causing pain and swelling. The study will test each drug separately and in combination to determine which is most effective in alleviating symptoms. Individuals with psoriatic arthritis symptoms for at least six months who have not responded well to one or two other treatments may be suitable candidates. Participants will attend regular hospital visits for check-ups, tests, and to monitor their response to the treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in psoriatic arthritis care.

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.

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

Research has shown that risankizumab is generally safe for treating psoriatic diseases. Long-term studies have not identified any new safety concerns. The most common side effect is upper respiratory tract infections, and serious medical issues are rare. Specifically, 4% of patients using risankizumab and 5.5% of those on a placebo experienced serious medical issues requiring attention.

Lutikizumab has also been tested in individuals with skin conditions like hidradenitis suppurativa. Patients reported better outcomes without major safety problems. However, specific safety data for its use in psoriatic arthritis is still being gathered.

The combination of lutikizumab and risankizumab is newer, so detailed safety information remains limited. This is a Phase 2 trial, indicating some initial safety in earlier studies, but it is still under evaluation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Risankizumab and Lutikizumab for psoriatic arthritis because they target specific pathways involved in the condition's inflammation. Most current treatments, like TNF inhibitors, broadly suppress the immune system, but Risankizumab focuses on the interleukin-23 (IL-23) pathway, offering a more targeted approach. Lutikizumab, on the other hand, targets interleukin-1 alpha and beta, further reducing inflammation with precision. This combination could potentially provide more effective control of symptoms with fewer side effects compared to existing therapies.

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

Research has shown that risankizumab, one of the treatments in this trial, effectively treats psoriatic arthritis. Studies have demonstrated that it reduces joint symptoms, pain, and fatigue, with many patients experiencing at least a 20% improvement, leading to less swelling and pain in the joints. Lutikizumab, another treatment option in this trial, has shown some potential for treating skin conditions, but its effectiveness for psoriatic arthritis remains uncertain. This trial will also explore whether combining risankizumab and lutikizumab offers better results, but clear findings on this combination are still being gathered. Overall, risankizumab alone has strong support for improving psoriatic arthritis symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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, 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06865105

NCT06865105 | Study of Targeted Therapies for the ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6390132/

Phase IIa, placebo-controlled, randomised study of ... Despite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo. Keywords ...

3. news.abbvie.com news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3

Lutikizumab Showed Positive Results in a Phase 2 Trial of ... Patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold ...

4. withpower.com withpower.com/trial/phase-2-arthritis-3-2025-334ea

Risankizumab + Lutikizumab for Psoriatic Arthritis In the phase 3 KEEPsAKE 2 trial involving 444 patients with psoriatic arthritis, risankizumab significantly improved disease outcomes compared to placebo, with ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/7/1/e001399

Comparative effectiveness of biologics and targeted ... Main outcomes include (1) treatment effectiveness, based on: adherence, adding or switching biologic or PDE4, addition of new non-biologic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489988/

Efficacy and safety of IL-17, IL-12/23, and IL-23 inhibitors for ... This NMA showed that IL-17, IL-12/23, and IL-23 inhibitors demonstrated remarkable efficacy in attaining ACR20, ACR50, ACR70, and MDA after 12, 16, or 24 weeks ...

7. ard.bmj.com ard.bmj.com/content/80/9/1147

Efficacy and safety of tildrakizumab in patients with active ... Conclusions Tildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally ...