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

Korábbi kezelés

• Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
• Previous exposure to sonelokimab.
• Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Más betegség

• 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.

Egyéb

• Participants who have an established diagnosis of arthritis mutilans.

• 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 test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
• Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.