BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BI 655066; BI 655066; Ustekinumab; BI 655066
Intervention description: Medium dose; High dose; Low dose
Intervention MeSH terms: Ustekinumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 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 in adult patients with chronic plaque psoriasis in order to
      select doses for further clinical trials.
    

Eligibility criteria:

        Inclusion criteria:

          -  Body Mass Index (BMI) >/= 18.5 and < 40 kg/m²

          -  Patients with stable moderate to severe chronic plaque-type psoriasis with or without
             psoriatic arthritis involving >/= 10% body surface area, with disease severity PASI
             >/= 12 and sPGA score of moderate and above (score of at least 3) at screening visit
             and visit 2 (randomisation), as assessed by the investigator

          -  Psoriasis disease duration of at least 6 months prior to screening, as assessed by the
             investigator

          -  Patients must be candidates for systemic psoriasis treatment or phototherapy, as
             assessed by the investigator

          -  Patients must be suitable candidates for ustekinumab (Stelara®) therapy as given in
             the local labelling

          -  Patient must give informed consent and sign an approved consent form prior to any
             study procedures in accordance with GCP and local legislation

        Exclusion criteria:

          -  Patients with guttate, erythrodermic, or pustular psoriasis and patients with
             drug-induced psoriasis, as diagnosed by the investigator

          -  Evidence of current or previous clinically significant disease, medical condition
             other than psoriasis, or finding of the medical examination (including vital signs and
             ECG), that in the opinion of the investigator, would compromise the safety of the
             patient or the quality of the data. This criterion provides an opportunity for the
             investigator to exclude patients based on clinical judgment, even if other eligibility
             criteria are satisfied. (Psoriatic arthritis is not considered an exclusion criterion)

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders, diseases of the central nervous system (such as
             epilepsy) or psychiatric disorders or neurological disorders, or history of
             orthostatic hypotension, fainting spells or blackouts, that in the investigator's
             judgement, could jeopardize the safe conduct of the study.

          -  Clinically important acute or chronic infections including hepatitis and HIV.

        With regards to tuberculosis the following applies:

        Have signs or symptoms suggestive of current active or latent TB upon medical history,
        physical examination and/or a chest radiograph (both posterior-anterior and lateral views,
        taken within 3 months prior to the first administration of study drug and read by a
        qualified radiologist).

        Have history of latent or active TB prior to screening, except for patients who have
        documentation of having completed an adequate treatment regimen at least 6 months prior to
        the first administration of study agent.

        Have positive IGRA testing (QuantiFERON-TB Gold) within 2 months prior to or during
        screening, in which active TB has not been ruled out, except for patients with history of
        latent TB and documentation of having completed an adequate treatment regimen at least 6
        months prior to the first administration of study agent.

          -  Have had a live vaccination </= 12 weeks prior to randomisation (visit 2). Patients
             must agree not to receive a live vaccination during the study. No BCG vaccines should
             be given for one year prior to randomisation (visit 2), during the study and for one
             year after last administration of study drug (according to the Stelara® SPC).

          -  History of clinically significant hypersensitivity to a systemically administered
             biologic agent or its excipients

          -  History of malignancy in the past 5 years or suspicion of active malignant disease
             except treated cutaneous squamous cell or basal cell carcinoma

          -  Has received any therapeutic agent directly targeted to IL-12, IL-23 (including
             ustekinumab (Stelara®))

          -  Use of biologic agents within 12 weeks (infliximab, etanercept, adalimumab, other
             biologics) prior to treatment, systemic anti-psoriatic medications or phototherapy
             within 4 weeks prior to treatment, or topical anti-psoriasis medications within 2
             weeks prior to treatment