This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
207
randomized treatment; parallel group
randomized treatment; parallel-group
randomized treatment; parallel-group
Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants who achieve ACR50 compared with baseline
Time frame: Week 12
Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)
Proportion of participants who achieve ACR20 compared with baseline
Time frame: Week 2, 4, 8, 12
Psoriasis Area and Severity Index (PASI) 90
Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Time frame: Week 4, 8, 12
Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria
Proportion of participants who achieve ACR70 compared with baseline
Time frame: Weeks 2, 4, 8, 12
Leeds Enthesitis Index (LEI)
Proportion of participants with resolution of enthesitis (LEI = 0)
Time frame: Weeks 4, 8, 12
Leeds Dactylitis Index (LDI)
Change from baseline for Leeds Dactylitis Index
Time frame: Weeks 4, 8, 12
Modified Nail Psoriasis Severity Index (mNAPSI)
Change from baseline for mNAPSI
Time frame: Week 12
Psoriasis Area and Severity Index (PASI) 100
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Clinical Site
Rancho Mirage, California, United States
Clinical Site
Duncansville, Pennsylvania, United States
Clinical Site
Pleven, Bulgaria
Clinical Site
Pleven, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Rousse, Bulgaria
Clinical Site
Sofia, Bulgaria
Clinical Site
Stara Zagora, Bulgaria
Clinical Site
Varna, Bulgaria
...and 32 more locations
Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Time frame: Weeks 4, 8, 12