a study to investigate efficacy, tolerability and safety of aby-035 in patients with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: 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).

Eligibility criteria:
inclusion criteria: * patient who has given his / her signed declaration of consent and data protection declaration * at least 18 years and less than 75 years of age at screening visit * psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the classification criteria for psoriatic arthritis (caspar) at any timepoint in medical history. * active psoriatic arthritis defined by: * ≥3 swollen joints out of 66 joints (sjc66) at screening visit and baseline visit * ≥3 tender joints out of 68 (tjc68) at screening visit and baseline visit * precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (nsaid), csdmard (i.e. mtx, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine a), and/or tnfi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab) * rheumatoid factor (rf) and anti-ccp antibody negative * presence or history of plaque psoriasis exclusion criteria: * underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy * history of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis * history of or current fibromyalgia or pain syndrome * uncontrolled inflammatory bowel disease * presence or history of recurrent or medically important infections in the last 6 months prior to baseline visit * clinically relevant candida infection requiring systemic treatment within the last 6 months prior to baseline visit * history or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years * insufficiently controlled heart failure * current uncontrolled arterial hyper- or hypotension