efficacy, safety and immunogenicity of bi 695501 versus humira® in patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

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.