BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: risankizumab; placebo for risankizumab
Intervention description: Risankizumab administered by SC injection; Placebo for risankizumab administered by SC injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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