SHS_280163 MEAP CBOH 16034

A Randomised, Double-blind, Placebo-controlled, Proof-of-concept, Dose-ranging Study of BI 655066 in Patients With Active Psoriatic Arthritis

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with psoriatic arthritis in order to select doses for further clinical trials.

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 TNFi agents, as assessed by the investigator
•Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
•Further inclusion criteria apply

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 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. 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 tuberculosis.
•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
•Further exclusion criteria apply
Phase II
All Other
Philip Mease, M.D.
Boehringer Ingelheim Pharmaceuticals, Inc
Sephren Barrow
  • Swedish Medical Center