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

NCT06488664 | Active Not Recruiting Phase 3

• 1 other identifier: UKM-PS-III
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 34

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.

Conditions

Plaque Psoriasis

Keywords

ustekinumab; humanized monoclonal antibodies; safety; plaque psoriasis; equivalence; biosimilar; PASI (Psoriasis Area and Severity Index); BSA (Body Surface Area); DLQI (Dermatological Life Quality Index); PGA (Physician's Global Assessment); immunogenicity

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above

  PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

  Week 12

Secondary Outcomes (9)

• The proportion of patients achieving PASI50/75/90/100

  Week 60

• Time to reach PASI50, PASI75, PASI90, PASI100

  Week 60

• Area under the curve (AUC) of PASI

  Week 60

• The proportion of partial responders (ie, patients achieving ≥50% but <75% improvement in PASI compared to baseline)

  Week 60

• Changes in the BSA index

  Week 60

Study Arms (2)

GNR-068 (JSC "GENERIUM", Russia)

EXPERIMENTAL

Test drug

Biological: GNR-068

Stelara® (manufacturer Silag AG, Switzerland)

ACTIVE COMPARATOR

reference drug

Biological: Stelara®

Interventions

GNR-068 BIOLOGICAL

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

Also known as: ustekinumab biosimilar

GNR-068 (JSC "GENERIUM", Russia)

Stelara® 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.

Also known as: ustekinumab

Stelara® (manufacturer Silag AG, Switzerland)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (34)

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

Barnaul, Barnaul, 656038, Russia

Location

State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary"

Chelyabinsk, Chelyabinsk Oblast, 454048, Russia

Location

Limited Liability Company "Ecology of Health"

Chelyabinsk, Chelyabinsk Oblast, 454126, Russia

Location

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

Yekaterinburg, Ekaterinburg, 620076, Russia

Location

Limited Liability Company "Alliance Biomedical - Ural Group"

Izhevsk, Izhevsk, 426061, Russia

Location

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, 610027, Russia

Location

Limited Liability Company "Available Polyclinic"

Murino, Leningradskaya Oblast', 188678, Russia

Location

State health care institution "Regional Dermatovenerological Dispensary"

Lipetsk, Lipetsk Oblast, 398005, Russia

Location

Limited Liability Company "OLLA-MED"

Moscow, Moscow, 105554, Russia

Location

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

Moscow, Moscow, 115522, Russia

Location

Limited Liability Company "Firma ORIS"

Moscow, Moscow, 117321, Russia

Location

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, 119071, Russia

Location

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, 127006, Russia

Location

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

Moscow, Moscow, 129110, Russia

Location

Limited Liability Company "Family Clinic No. 4"

Korolyov, Moscow Oblast, 141060, Russia

Location

Limited Liability Company "Medical Center "Healthy Family"

Novosibirsk, Novosibirsk Oblast, 630099, Russia

Location

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

Orenburg, Orenburg Oblast, 460018, Russia

Location

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

Ryazan, Ryazan Oblast, 390046, Russia

Location

Limited Liability Company "Clinic of Skin Diseases Pierre Wolkenstein"

Saint Petersburg, Sankt-Peterburg, 191123, Russia

Location

Limited Liability Company "International Medical Center"

Saint Petersburg, Sankt-Peterburg, 191123, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 192148, Russia

Location

Limited Liability Company "Health Energy"

Saint Petersburg, Sankt-Peterburg, 194156, Russia

Location

Limited Liability Company "Interleukin"

Saint Petersburg, Sankt-Peterburg, 194214, Russia

Location

Limited Liability Company "Institute of Medical Research"

Saint Petersburg, Sankt-Peterburg, 196084, Russia

Location

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Sankt-Peterburg, 196143, Russia

Location

Limited Liability Company "PiterKlinika"

Saint Petersburg, Sankt-Peterburg, 196158, Russia

Location

Limited Liability Company "ArsVite North-West"

Saint Petersburg, Sankt-Peterburg, 196191, Russia

Location

Limited Liability Company "Curator"

Saint Petersburg, Sankt-Peterburg, 196240, Russia

Location

Private medical institution "Euromedservice"

Saint Petersburg, Sankt-Peterburg, 196603, Russia

Location

Limited Liability Company "MEDINET"

Saint Petersburg, Sankt-Peterburg, 197136, Russia

Location

Limited Liability Company "SB Clinic of Cosmetology"

Saratov, Saratov Oblast, 410012, Russia

Location

Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary"

Smolensk, Smolensk Oblast, 214031, Russia

Location

Limited Liability Company Medical Center "Azbuka Health"

Kazan', Tatarstan Republic, 420111, Russia

Location

State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 25, 2023
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (34)