RecruitingArthritis, Psoriatic

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

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: MoonLake Immunotherapeutics AG

You may qualify if…

✓ 1. Participants must be ≥18 years of age .
✓ 2. 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.
✓ 3. Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
✓ 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
✓ 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
✓ 6. 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.

You may not qualify if…

✕ 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
✕ 2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
✕ 3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
✕ 4. Participants with a diagnosis of inflammatory bowel disease.
✕ 5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
✕ 6. Participants who have an established diagnosis of arthritis mutilans.
✕ 7. Previous exposure to sonelokimab.
✕ 8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα