Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BI 695501; Humira
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in
      patients with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females aged >=18 to =<80 years who have a diagnosis of moderate to severe
             chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months
             before the first administration of study drug (a self-reported diagnosis confirmed by
             the investigator is acceptable), and which has been stable for the last 2 months with
             no changes in morphology or significant flares at both Screening and Baseline
             (Randomization):

               -  involved body surface area (BSA) >= 10% and

               -  Psoriasis Area and Severity Index (PASI) score >= 12 and

               -  static Physician's Global Assessment (sPGA) score of >= 3.

          -  Participants of reproductive potential (childbearing potential ) must be willing and
             able to use highly effective methods of birth control per International Council for
             Harmonization (ICH) M3 (R2) that result in a low failure rate of less than 1% per year
             when used consistently and correctly during the trial and for 6 months following
             completion or discontinuation from the trial medication.

          -  Signed and dated written informed consent in accordance with Good Clinical Practice
             (GCP) and local legislation prior to admission to the trial.

          -  Patients who are candidates for systemic therapy.

        Exclusion criteria:

          -  Active ongoing inflammatory diseases other than psoriasis that might confound trial
             evaluations according to investigator's judgment.

          -  Previous treatment with more than 1 biological agent, or adalimumab or adalimumab
             biosimilar. No prior biologic exposure within last 6 months of screening.

          -  Patients with a significant disease other than psoriasis and/or a significant
             uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic,
             endocrine, hematological, autoimmune or gastrointestinal disorders).

          -  Major surgery performed within 12 weeks prior to randomization or planned within 6
             months after screening, e.g., total hip replacement.

          -  Any documented active or suspected malignancy or history of malignancy within 5 years
             prior to screening, except appropriately treated basal cell carcinoma of the skin or
             in situ carcinoma of uterine cervix.

          -  Patients who must or wish to continue the intake of restricted medications or any drug
             considered likely to interfere with the safe conduct of the trial.

          -  Currently enrolled in another investigational device or drug study, or less than 30
             days since ending another investigational device or drug study(s), or receiving other
             investigational treatment(s).

          -  Chronic alcohol or drug abuse

          -  Women who are pregnant, nursing, or who plan to become pregnant during the course of
             this study or within the period at least 6 months following completion or
             discontinuation from the trial.

          -  Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic
             plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from
             e.g., beta blockers or lithium).

          -  Primary or secondary immunodeficiency (history of, or currently active), including
             known history of HIV infection or a positive HIV test at screening (per the
             investigator discretion and where mandated by local authorities).

          -  Known chronic or relevant acute tuberculosis; no evidence of active tuberculosis.

          -  Known clinically significant coronary artery disease, significant cardiac arrhythmias,
             moderate to severe congestive heart failure (New York Heart Association Classes III or
             IV) or interstitial lung disease observed on chest X-ray.

          -  History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a
             previously used biological drug or its excipients.

          -  Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV).

          -  Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit;
             patients who are expecting to receive any live/attenuated virus or bacterial
             vaccinations during the trial or up to 3 months after the last dose of trial drug.

          -  Any treatment (including biologic therapies) that, in the opinion of the investigator,
             may place the patient at unacceptable risk during the trial.

          -  Known active infection of any kind (excluding fungal infections of nail beds), any
             major episode of infection requiring hospitalization or treatment with intravenous
             (i.v.) anti infectives within 4 weeks of the Screening Visit

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper
             limit of normal (ULN) at Screening.

          -  Hemoglobin < 8.0 g/dL at Screening.

          -  Platelets < 100,000/µL at Screening.

          -  Leukocyte count < 4000/µL at Screening.

          -  Creatinine clearance < 60 mL/min/1.73 m2 at Screening.

          -  Patients with a history of any clinically significant adverse reaction to murine or
             chimeric proteins, or natural rubber and latex, including serious allergic reactions.