Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMoonLake Immunotherapeutics AG

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

600 Participants
are divided into 4 treatment groups

Sponsors and collaborators