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

AbbVie

Status and phase: Enrolling; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: Risankizumab; Drug: Lutikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06865105

M25-191

Details and patient eligibility

About

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 sub-study 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.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Sub-Study 1: Risankizumab Monotherapy

Experimental group

Description:

Participants will receive Risankizumab

Treatment:

Drug: Risankizumab

Sub-Study 1: Lutikizumab Monotherapy

Experimental group

Description:

Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.

Treatment:

Drug: Lutikizumab

SubStudy 1: Lutikizumab and Risankizumab Combination Therapy

Experimental group

Description:

Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.

Treatment:

Drug: Lutikizumab

Drug: Risankizumab