An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis

Prior treatment

• Types of psoriasis other than plaque, except for concomitant psoriatic arthritis.
• Therapy with TNF-alpha inhibitors or any other genetically engineered biological drugs within 3 months before randomization.
• Conducting other systemic therapies (including cyclosporine, acitretin, methotrexate, UV and PUVA therapy) within 1 month before randomization.
• Treatment with leflunomide for 6 months before randomization.
• Major surgery (including joint surgery) within 8 weeks before the start of the study or elective surgery within 6 months after the start of the study.
• Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study drug or comparator drug.
• Concomitant diseases and conditions that, in the opinion of the Investigator and/or Sponsor, jeopardize the safety of the patient during participation in the study, or which will influence the analysis of safety data.
• Active systemic infection (bacterial, viral or fungal) within 14 days before signing the informed consent.
• Participation in clinical trials of drugs less than 5 half-lives of the study drug before signing the informed consent.

Other illness

• History of therapy with ustekinumab or any therapy aimed at IL-12 or IL-23 (briakinumab, guselkumab, tildrakizumab).
• Spread of the inflammatory process involving the gastrointestinal tract (inflammatory bowel diseases), the organ of vision (uveitis, iridocyclitis), musculoskeletal structures (high activity of psoriatic arthritis, osteoarthritis, uncontrolled against the background of basic therapy (clause 3 Inclusion criteria) ).
• A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
• History of tuberculosis, positive/doubtful result of screening for tuberculosis infection (tuberculosis allergen test or IGRA test or fluorography results). Inclusion of such patients is possible if effective specific treatment for tuberculosis infection has been carried out and there is a conclusion from a phthisiatrician about the possibility of ustekinumab therapy.
• Positive test for hepatitis B or C, HIV or syphilis.
• Identification during screening of other diseases/conditions not listed above that, in the opinion of the physician-researcher, prevent the inclusion of the patient in the study.

Lab values

• A history of a disease associated with the accumulation of immune complexes that may distort the assessment of the effectiveness of ustekinumab therapy (including serum sickness, systemic lupus erythematosus, rheumatoid arthritis, polymyositis, scleroderma, Sjogren's syndrome, vasculitis, cryoglobulinemia).

Other

• Pregnancy or breastfeeding.
• Unwillingness or inability to comply with the recommendations prescribed by this protocol.

• Written informed consent to participate in the study.
• Men and women 18-75 years of age, inclusive, at the time of signing the informed consent form.
• Patients diagnosed with plaque psoriasis at least 6 months before screening:
  • Moderate or severe form of the disease, which is defined as: PASI index ≥12, body surface area (BSA) affected by plaque psoriasis, ≥10%, PGA scale score ≥3 (on a scale from 0 to 4).
  • Presence of indications for systemic therapy, defined as inadequate control of the disease against the background of: local treatment (including local glucocorticosteroids) and/or phototherapy and/or lack of clinical effect from the use of other systemic methods.
  • It is acceptable to carry out basic therapy for psoriatic arthritis at a stable dose for ≥ 4 weeks before screening: prednisolone at a dose of ≤10 mg per day, NSAIDs, methotrexate at a dose of ≤15 mg per week, sulfasalazine at a dose of 2.0 g per day.
• Body weight less than 100 kg.
• If it is necessary to take drugs that worsen the course of psoriasis (beta blockers, calcium channel blockers, lithium drugs, etc.): a stable dose of these drugs for ≥ 4 weeks before randomization.
• Consent of women of childbearing age, women in menopause lasting less than 2 years and male patients to comply with adequate methods of contraception throughout the study and for 3 months after the end of ustekinumab therapy.
• Patients should not be donors of blood or its components 30 days before inclusion in the study and not become donors of blood or its components throughout the study and for 3 months after its completion.