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

Launched by ABBVIE · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating new treatments for adults with active psoriatic arthritis (PsA), a condition where the immune system mistakenly attacks healthy joints, causing pain, stiffness, and swelling. The study will look at the effectiveness and safety of two targeted therapies, risankizumab and lutikizumab, either on their own or in combination. Around 120 participants will be enrolled from various locations worldwide, and they will be randomly assigned to one of three treatment groups.

To be eligible for this trial, participants should have been diagnosed with PsA for at least six months and currently experience active symptoms, such as tender and swollen joints. They must also have not responded well to one or two previous treatments for PsA. Participants can expect to attend regular visits to a hospital or clinic where their health will be monitored through evaluations, blood tests, and questionnaires. It’s important to note that participants may have more appointments and procedures than they would with standard treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).