This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.
The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up. Treatment Periods are: * Treatment Period I: from V1 (Week 0) to V9 (Week 16) * Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing) At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C). The treatment will be administered once every 2 weeks (Q2W). Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
129
American College of Rheumatology 50 response rate (ACR50)
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
Time frame: 16 weeks
ACR50
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
Time frame: 12 weeks
ACR20/70
ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo
Time frame: 16 weeks
ACR20/70
ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
Time frame: 12 weeks
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo
Time frame: 16 weeks
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo
Time frame: 12 weeks
ACR 20/50/70
ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo
Time frame: 8 weeks
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LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
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