Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Re… (NCT06641089) | Clinical Trial Compass
RecruitingPhase 3
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
United States600 participantsStarted 2024-10-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 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 PsO whether investigational or approved, except for those targeting TNFα