This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Participants must be ≥18 years of age .
Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
Participants with a known hypersensitivity to sonelokimab or any of its excipients.
Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
Participants with a diagnosis of inflammatory bowel disease.
Parallel
Sonelokimab
DrugSonelokimab
Placebo
DrugPlacebo
Risankizumab
DrugActive comparator
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants achieving ACR50
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Proportion of participants achieving ACR20
Response rate of participants achieving Minimal Disease Activity (MDA)
Proportion of participants achieving MDA
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Change in HAQ-DI from baseline
Psoriasis Area and Severity Index (PASI90)
Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
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