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

Inclusion Criteria:

• Written informed consent to participate in the study.

• Men and women 18-75 years of age, inclusive, at the time of signing the informedconsent form.

• Patients diagnosed with plaque psoriasis at least 6 months before screening:

1. 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).

2. Presence of indications for systemic therapy, defined as inadequate control ofthe disease against the background of: local treatment (including localglucocorticosteroids) and/or phototherapy and/or lack of clinical effect fromthe use of other systemic methods.

3. It is acceptable to carry out basic therapy for psoriatic arthritis at a stabledose 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 ≥ 4weeks before randomization.

• Consent of women of childbearing age, women in menopause lasting less than 2 yearsand male patients to comply with adequate methods of contraception throughout thestudy and for 3 months after the end of ustekinumab therapy.

• Patients should not be donors of blood or its components 30 days before inclusion inthe study and not become donors of blood or its components throughout the study andfor 3 months after its completion.

Exclusion Criteria:

• Types of psoriasis other than plaque, except for concomitant psoriatic arthritis.

• History of therapy with ustekinumab or any therapy aimed at IL-12 or IL-23 (briakinumab, guselkumab, tildrakizumab).

• Therapy with TNF-alpha inhibitors or any other genetically engineered biologicaldrugs 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.

• 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) ).

• Major surgery (including joint surgery) within 8 weeks before the start of the studyor elective surgery within 6 months after the start of the study.

• A history of an adverse drug reaction to any of the components of the study drug ora reference drug.

• Immunization with any live or live attenuated vaccine within 1 month before thefirst dose of the study drug or comparator drug.

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

• Concomitant diseases and conditions that, in the opinion of the Investigator and/orSponsor, jeopardize the safety of the patient during participation in the study, orwhich will influence the analysis of safety data.

• Active systemic infection (bacterial, viral or fungal) within 14 days before signingthe informed consent.

• Pregnancy or breastfeeding.

• History of tuberculosis, positive/doubtful result of screening for tuberculosisinfection (tuberculosis allergen test or IGRA test or fluorography results).Inclusion of such patients is possible if effective specific treatment fortuberculosis infection has been carried out and there is a conclusion from aphthisiatrician about the possibility of ustekinumab therapy.

• Participation in clinical trials of drugs less than 5 half-lives of the study drugbefore signing the informed consent.

• Positive test for hepatitis B or C, HIV or syphilis.

• Unwillingness or inability to comply with the recommendations prescribed by thisprotocol.

• Identification during screening of other diseases/conditions not listed above that,in the opinion of the physician-researcher, prevent the inclusion of the patient inthe study.