Shelby Research

Abbvie clinical trial for Psoriatic arthritis (PsA)

Abbvie clinical trial for Psoriatic arthritis (PsA)

NOW ENROLLING

This study will evaluate the Efficacy and Safety of targeted therapies through a series of sub-studies, for the treatment of Active Psoriatic Arthritis and to assess the changes in disease symptoms.

Trial Details

Brief Summary: The primary objective is to evaluate the efficacy and safety 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.

Condition or disease
Psoriatic arthritis (PsA

Intervention/treatment
Drug: Lutikizumab
Drug: Risankizumab

Phase
Phase 2

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

    • ***Additional inclusion criteria are defined in the protocol.

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).

    • ***Other protocol-defined inclusion/exclusion criteria may apply


View Trial on ClinicalTrials.gov website: NCT06865105