bi 655066/abbv-066/risankizumab compared to placebo in patients with active psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of bi 655066/abbv-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.


Eligibility criteria:
inclusion criteria: * have psoriatic arthritis (psa) symptoms for ≥ 6 months prior to screening, as assessed by the investigator * have psa on the basis of the classification criteria for psoriatic arthritis (caspar) with peripheral symptoms at screening visit, as assessed by the investigator * have ≥ 5 tender joints and ≥ 5 swollen joints at screening and randomisation visits, as assessed by the investigator * at least one psoriasis (pso) lesion or a documented personal history of pso at screening, as assessed by the investigator * if patients receive concurrent psa treatments, these need to be on stable doses * active psa that has been inadequately controlled by standard doses of non-steroidal anti-inflammatory drugs (nsaids) administered for ≥ 4 weeks, or traditional disease-modifying anti-rheumatic drugs (dmards) (including sulfasalazine) administered for ≥ 3 months, or tumor necrosis factor inhibitor (tnfi) agents, or subjects are intolerant to nsaids or dmards or tumor necrosis factor inhibitor (tnfi) agents, as assessed by the investigator exclusion criteria: * major chronic inflammatory or connective tissue disease other than psa (e.g. rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, lyme disease, gout) and fibromyalgia, as assessed by the investigator * has received any therapeutic agent directly targeted to interleukin 12/23 (il-12/23) (including ustekinumab), il-23 or il-17 (including secukinumab) * prior use of more than two different tnfi agents * use of the following treatments: tnfi agents within 12 weeks, etanercept within 8 weeks, leflunomide without cholestyramine wash-out within 8 weeks, systemic non-biologic medications for psoriatic arthritis or psoriasis and photochemotherapy within 4 weeks, intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks, topical psoriasis medications and phototherapy within 2 weeks, low and high potency opioid analgesics within 2 weeks prior to randomisation * plans for administration of live vaccines during the study period or within 6 weeks prior to randomisation * history of allergy/hypersensitivity to a systemically administered biologic agent or its excipients * active systemic infections during the last 2 weeks (exception: common cold) prior to randomisation, as assessed by the investigator * chronic or relevant acute infections including hiv, viral hepatitis and (or) active tuberculosis (tb). patients with a positive quantiferon tb or purified protein derivate (ppd) test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tb. * any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix * major surgery performed within 12 weeks prior to randomisation or planned within 32 weeks after randomisation (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator * total white blood count (wbc) \< 3,000/µl, or platelets \< 100,000/µl or neutrophils \< 1,500/µl, or hemoglobin \< 8.5 g/dl at screening * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2x the upper limit of normal, or serum direct bilirubin ≥ 1.5 mg/dl at screening * positive rheumatoid factor or anti-cyclic-citrullinated peptide (anti-ccp) antibodies at screening