| Participants |
Randomised: 344 participants
Inclusion criteria
Participant had written informed consent Age between 18 and 75 years. Participant has moderate‐to‐severe plaque psoriasis with stable course of the disease for 6 months Participant has had at least 1 course of phototherapy or systemic treatment for psoriasis or are candidates for such treatment in opinion of Investigator BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3 Participant has haemoglobin ≥ 10 g/dl, leucocytes count ≥ 3000/mcl, thrombocytes count ≥ 100,000/mcl, neutrophil count ≥ 2000/mcl, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase exceed 2.5 or less times the upper limit of the normal range creatinine less than 176.8 µmol/l, no serologic or virologic markers of hepatitis B virus or hepatitis C virus, negative urine pregnancy test, no signs of tuberculosis (negative tuberculosis skin test or negative quantiferon test. Patients can be included in they have positive tuberculin test, have had Bacteria Calmette‐Guerin (BCG) vaccination and have negative Diaskintest or negative quantiferon test. Patients can be included if they have positive tuberculin test, have not been vaccinated with BCG and also patients with positive or uncertain quantiferon test/Diaskintest if they have documented adequate prophylaxis of tuberculosis finished before first adalimumab injection AND have documented absence of contacts with patients who have active tuberculosis AND have no signs of tuberculosis on chest X‐ray that was performed during 3 months before randomisation) Participants are able to perform all procedures planed by protocol Participants are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug
Exclusion criteria
Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication‐induced psoriasis, or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of investigational product on psoriasis Previous receipt of adalimumab, history of use of any other biological anti‐tumour necrosis factor‐alpha therapy. Prior use of 2 or more biologics for treatment of psoriasis Previous receipt of monoclonal antibodies if they were cancelled less than 12 weeks before screening Taking corticosteroids for up to 4 weeks before signing informed consent and during screening, disease‐modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, leflunomide, cyclophosphamide for up to 6 months before signing informed consent, phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent, live or attenuated vaccines for up to 8 weeks before signing informed consent Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid phototherapySubject has a planned surgical intervention during the study or had surgical intervention less than 30 days prior to study Has an active infection or history of infections as follows: any active infection for which systemic anti‐infectives were used within 28 days prior to signing informed consent; a serious infection, defined as requiring hospitalisation or intravenous anti‐infectives within 8 weeks prior to signing informed consent; recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the person Has known history of HIV or any other severe immunodeficiency Hepatitis B surface antigen or Hepatitis B core antigen or Hepatitis C antibody positivity at screening History of tuberculosis. Positive results of rapid plasma reagin‐test for T. pallidum at screening Active ongoing diseases other than psoriasis that might confound the evaluation of the benefit of treatment of adalimumab or can increase risk of adverse reactions: acute inflammatory diseases or exacerbation of chronic diseases other than psoriasis; stable ischaemic heart disease III‐IV functional class, unstable angina or history of myocardial infarction less than 1 year before the signing of informed consent; moderate‐to‐severe heart failure (New York Heart Association [NYHA] class III/IV); severe resistant arterial hypertension, atopic bronchial asthma, history of angio‐oedema, moderate‐to‐severe respiratory insufficiency, chronic obstructive lung disease 3 ‐ 4 grade, decompensated diabetes mellitus, systemic autoimmune diseases, active neurologic disorders or their symptoms, other underlying condition (including, but not limited to metabolic, haematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the person and/or places them at unacceptable risk for receiving an immunomodulatory therapy. Has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma Has a history of hypersensitivity to the active substance or to any of the excipients of adalimumab or BCD‐057 or other monoclonal antibodies Woman who is pregnant or breast‐feeding or considering becoming pregnant during the study Has any mental illness, including severe depressive disorders and/or suicidal thoughts in history, which, in the opinion of the investigator, may create excessive risk to the person or to influence their ability to follow the protocol History of drug addiction, alcoholism Simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation; previous participation in this study
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| Interventions |
Intervention
BCD‐057 group includes participants with moderate‐to‐severe plaque psoriasis, who will receive BCD‐057 SC at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23
Control interventions
Humira® group includes participants with moderate‐to‐severe plaque psoriasis, who will receive Humira® SC at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
