Tests targeted therapies in adults with active psoriatic arthritis

Trial details

Who runs it

AbbVie

Trial code

NCT06865105

Record updated

9 November 2026

Original description

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.Read full original descriptionShow less

A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis

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 study are risankizumab, lutikizumab, ABBV-701, and ABBV-547. In Substudy 1, 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. In Substudy 2, participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: ABBV-701 monotherapy, risankizumab monotherapy, or a combination therapy of ABBV-701 and risankizumab. In Substudy 3, participants will be randomized in a 1:1:1 ratio to one of three doses of ABBV-547. Around 300 participants will be enrolled in the study at approximately 110 sites worldwide.

Inclusion: Participant is willing and able to comply with procedures required in the Master Protocol and relevant, actively enrolling 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 Visit; Participant has active plaque PsO, with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with PsO at Screening Visit; 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); 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); Participants with the following active, chronic, or recurring 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.

ClinicalTrials.gov NCT06865105