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Study of Lutikizumab and Risankizumab for Psoriatic Arthritis

This study is looking into new ways to treat active psoriatic arthritis (PsA), a condition where your immune system attacks your joints, causing pain and swelling. We are testing two targeted therapies, lutikizumab and risankizumab, to see how well they work and if they are safe. You would be randomly assigned to receive lutikizumab alone, risankizumab alone, or a combination of both. We will measure how much your symptoms improve, specifically looking for a 50% improvement in your arthritis symptoms by week 16, and track any side effects for up to 52 weeks. About 120 adults with a confirmed diagnosis of PsA will participate.

Study design
This study will involve about 120 participants who will be randomly assigned to one of three treatment groups: lutikizumab, risankizumab, or a combination of both.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to 52 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06865105

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~120 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:LutikizumabRisankizumab

At a glance

Recruiting sites
36 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Measured over At Week 16
+1 more outcome measured

Conditions

Psoriatic Arthritis

Explore related trials

Psoriatic Arthritis

Where it's being run

37 sites across 25 states
Florida5
Texas4
Illinois2
Czechia2
Fejér2
Hungary2
Masovian Voivodeship2
California1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant is willing and able to comply with procedures required in the Master Protocol and substudies.
Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit.
Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
Participant has active plaque PsO and/or a documented history of plaque PsO.
Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA

Exclusion

Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation).
Participants with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)
Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO.
History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

What this trial measures

  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) ResponseAt Week 16

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

  • Number of Participants With Adverse Events (AEs)Up to Week 52

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.