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

Study Identifier
M25-191
CT.gov Identifier
NCT06865105
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Psoriatic Arthritis (PsA)
    • Study Drug
  • Lutikizumab
  • Risankizumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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).

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Newport Huntington Medical Group /ID# 272764
    Huntington Beach, California, United States, 92648-5994
    Status
    Recruiting
    Location
    Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
    Avon Park, Florida, United States, 33825
    Status
    Recruiting
    Location
    Clinical Research Of West Florida - Phase I Unit /ID# 273198
    Clearwater, Florida, United States, 33765
    Status
    Recruiting
    Location
    HMD Research LLC /ID# 273086
    Orlando, Florida, United States, 32819
    Status
    Recruiting
    Location
    West Broward Rheumatology Associates /ID# 272892
    Tamarac, Florida, United States, 33321
    Status
    Recruiting
    Location
    Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
    Tampa, Florida, United States, 33606
    Status
    Recruiting
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