BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis

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

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