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

NCT ID: NCT06488664

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2025-09-30

Brief Summary

This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms of plaque psoriasis. Participants received a subcutaneous dose of ustekinumab 45 mg (GNR-068 or Stelara®) at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg. For patients with partially respond to the initial regimen the regimen can be adjusted.

Detailed Description

The drug GNR-068 (INN: ustekinumab) is being developed as a biosimilar to the drug Stelara®, solution for subcutaneous administration (Silag AG, Switzerland).

Preclinical studies and early phase clinical studies suggest that interleukins-12 (IL-12) and -23 (IL-23), two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. Ustekinumab is a monoclonal antibody directed against IL-12 and IL-23. This is a randomized, single blind, parallel-group, multicenter study to determine the effectiveness and safety of ustekinumab biosimilar GNR-068 administered subcutaneously as compared with Stelara® in patients with moderate to severe plaque-type psoriasis. Patients receive GNR-068 45 mg or Stelara 45 mg administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28, thereafter until week 52 all patients receive GNR-068. For patients who partially respond to the initial regimen, the dose can be adjusted to 90 mg and then the interval can be adjusted to every 8 weeks. The study included a screening period, comparative treatment period, non-comparative treatment period, follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1. 422 patients (211 to each study groups) were randomized.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GNR-068 (JSC "GENERIUM", Russia)

Test drug

Group Type: EXPERIMENTAL

GNR-068

Intervention Type: BIOLOGICAL

GNR-068 was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52.

Stelara® (manufacturer Silag AG, Switzerland)

reference drug

Group Type: ACTIVE_COMPARATOR

Stelara®

Intervention Type: BIOLOGICAL

Stelara® was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg until week 52.

Interventions

GNR-068

GNR-068 was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52.

Intervention Type: BIOLOGICAL

Stelara®

Stelara® was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg until week 52.

Intervention Type: BIOLOGICAL

Other Intervention Names

ustekinumab biosimilar; ustekinumab

Eligibility Criteria

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 informed consent 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 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.

3. 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.

• 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.
• A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
• Immunization with any live or live attenuated vaccine within 1 month before the first dose of the study drug or comparator drug.
• 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).
• 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.
• Pregnancy or breastfeeding.
• 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.
• Participation in clinical trials of drugs less than 5 half-lives of the study drug before signing the informed consent.
• Positive test for hepatitis B or C, HIV or syphilis.
• Unwillingness or inability to comply with the recommendations prescribed by this protocol.
• 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.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO GENERIUM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oksana A. Markova, MD

Role: STUDY_CHAIR

JSC GENERIUM

Locations

Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation

Barnaul, Barnaul, Russia

State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"

Chelyabinsk, Chelyabinsk Oblast, Russia

Limited Liability Company "Ecology of Health"

Chelyabinsk, Chelyabinsk Oblast, Russia

State budgetary institution of the Sverdlovsk region "Ural Research Institute of Dermatovenereology and Immunopathology"

Yekaterinburg, Ekaterinburg, Russia

Limited Liability Company "Alliance Biomedical - Ural Group"

Izhevsk, Izhevsk, Russia

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation (FSBEI HE Kirov State Medical University of the Ministry of Health of Russia))

Kirov, Kirov Oblast, Russia

Limited Liability Company "Available Polyclinic"

Murino, Leningradskaya Oblast', Russia

State health care institution "Regional Dermatovenerological Dispensary"

Lipetsk, Lipetsk Oblast, Russia

Limited Liability Company "OLLA-MED"

Moscow, Moscow, Russia

Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova"

Moscow, Moscow, Russia

Limited Liability Company "Firma ORIS"

Moscow, Moscow, Russia

State budgetary healthcare institution of the city of Moscow "Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Health Department"

Moscow, Moscow, Russia

Federal State Budgetary Educational Institution of Higher Education "Russian University of Medicine" of the Ministry of Health of the Russian Federation (FSBEI HE "Russian University of Medicine" of the Ministry of Health of Russia)

Moscow, Moscow, Russia

State budgetary healthcare institution of the Moscow region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"

Moscow, Moscow, Russia

Limited Liability Company "Family Clinic No. 4"

Korolyov, Moscow Oblast, Russia

Limited Liability Company "Medical Center "Healthy Family"

Novosibirsk, Novosibirsk Oblast, Russia

Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia

Orenburg, Orenburg Oblast, Russia

State budgetary institution of the Ryazan region "Regional clinical dermatovenerological dispensary"

Ryazan, Ryazan Oblast, Russia

Limited Liability Company "Clinic of Skin Diseases Pierre Wolkenstein"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "International Medical Center"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Medical Technologies" LLC "Medical Technologies"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Health Energy"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Interleukin"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Institute of Medical Research"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "PiterKlinika"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "ArsVite North-West"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "Curator"

Saint Petersburg, Sankt-Peterburg, Russia

Private medical institution "Euromedservice"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "MEDINET"

Saint Petersburg, Sankt-Peterburg, Russia

Limited Liability Company "SB Clinic of Cosmetology"

Saratov, Saratov Oblast, Russia

Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary"

Smolensk, Smolensk Oblast, Russia

Limited Liability Company Medical Center "Azbuka Health"

Kazan', Tatarstan Republic, Russia

State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, Russia

Countries

Russia

Other Identifiers

UKM-PS-III

Identifier Type: -

Identifier Source: org_study_id