Phase
Condition
Psoriatic Arthritis
Joint Injuries
Treatment
Sonelokimab
Risankizumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥18 years of age .
Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 monthsbefore the Screening Visit.
Participants have moderate to severe active disease (defined by a 68 tender jointcount [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmedhistory of plaque PsO.
Participants test negative for both rheumatoid factor and anti-cyclic citrullinatedpeptide at the Screening Visit.
Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must haveexperienced an inadequate response to treatment with the TNFα inhibitor(s) given atan approved dose for ≥3 months or have stopped treatment due to safety/tolerabilityproblems after ≥1 administration of a TNFα inhibitor.
Exclusion
Exclusion Criteria:
Participants with a known hypersensitivity to sonelokimab or any of its excipients.
Participants with a known hypersensitivity, or any contraindication, to risankizumabor any of its excipients.
Participants who have a diagnosis of chronic inflammatory conditions other than PsOor PsA.
Participants with a diagnosis of inflammatory bowel disease.
Participants who have experienced a period of ≥3 weeks of unexplained diarrhea inthe 24 weeks before the Baseline Visit.
Participants who have an established diagnosis of arthritis mutilans.
Previous exposure to sonelokimab.
Participants who have ever received biologic immunomodulating agents for PsA or PsOwhether investigational or approved, except for those targeting TNFα
Study Design
Study Description
Connect with a study center
Clinical Site
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Clinical Site
Upland, California 91786
United StatesActive - Recruiting
Clinical Site
Middleburg Heights, Ohio 44130
United StatesActive - Recruiting
Clinical Site
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Clinical Site
Memphis, Tennessee 38119
United StatesActive - Recruiting
Clinical Site
Allen, Texas 75013
United StatesActive - Recruiting
Clinical Site
Colleyville, Texas 76034
United StatesActive - Recruiting
Clinical Site
Grapevine, Texas 76051
United StatesActive - Recruiting
Clinical Site
Lubbock, Texas 79424
United StatesActive - Recruiting
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