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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 weakened immune system 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

Lutikizumab

Subcutaneous (SC) Injection

DRUG

Risankizumab

Subcutaneous (SC) Injection

Locations (20)

Newport Huntington Medical Group /ID# 272764
Huntington Beach, California, United States
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
Avon Park, Florida, United States
Clinical Research Of West Florida - Phase I Unit /ID# 273198
Clearwater, Florida, United States
HMD Research LLC /ID# 273086
Orlando, Florida, United States
West Broward Rheumatology Associates /ID# 272892
Tamarac, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
Tampa, Florida, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879
Skokie, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 277354
Willowbrook, Illinois, United States
Klein And Associates /ID# 272829
Hagerstown, Maryland, United States
Paramount Medical Research and Consulting /ID# 272757
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research /ID# 272593
Duncansville, Pennsylvania, United States
Private Practice - Dr. Ramesh C. Gupta I /ID# 272897
Memphis, Tennessee, United States
Tekton Research - West Gate /ID# 272765
Austin, Texas, United States
Accurate Clinical Research - Houston /ID# 272754
Houston, Texas, United States
Tekton Research, LLC /ID# 272901
San Antonio, Texas, United States
Dynamed Clinical Research - Tomball /ID# 272760
Tomball, Texas, United States
Centre de Recherche Musculo-Squelettique /ID# 274397
Trois-Rivières, Quebec, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 272803
Saskatoon, Saskatchewan, Canada
Revmatologie /ID# 272367
Brno, Brno-mesto, Czechia
L.K.N. Arthrocentrum /ID# 272366
Hlučín, Moravskoslezský kraj, Czechia