About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sonelokimab
- Placebo
- Risankizumab
Treatment groups
Locations
138Sponsors and collaborators
MoonLake Immunotherapeutics AG
Lead sponsor