Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis

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.