An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis
NCT Number: NCT06488664
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Plaque Psoriasis
Interventions: BIOLOGICAL: GNR-068|BIOLOGICAL: Stelara®
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 422
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-25
Completion Date: 2025-03-20
Locations: Limited Liability Company "Available Polyclinic", Murino, Leningrad Region, 188678, Russian Federation|Limited Liability Company "Family Clinic No. 4", Korolev, Moscow Region, 141060, Russian Federation|Limited Liability Company Medical Center "Azbuka Health", Kazan, Republic Of Tatarstan, 420111, Russian Federation|Limited Liability Company "Clinic of Skin Diseases Pierre Wolkenstein", St. Petersburg, Saint Petersburg, 191123, Russian Federation|Limited Liability Company "International Medical Center", St. Petersburg, Saint Petersburg, 191123, Russian Federation|Limited Liability Company "Health Energy", St. Petersburg, Saint Petersburg, 194156, Russian Federation|Limited Liability Company "Institute of Medical Research", St. Petersburg, Saint Petersburg, 196084, Russian Federation|Limited Liability Company "PiterKlinika", St. Petersburg, Saint Petersburg, 196158, Russian Federation|Private medical institution "Euromedservice", St. Petersburg, Saint Petersburg, 196603, Russian Federation|Limited Liability Company "MEDINET", St. Petersburg, Saint Petersburg, 197136, Russian Federation|Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation, Barnaul, 656038, Russian Federation|State budgetary healthcare institution "Chelyabinsk Regional Clinical Dermatovenerological Dispensary", Chelyabinsk, 454048, Russian Federation|Limited Liability Company "Ecology of Health", Chelyabinsk, 454126, Russian Federation|State budgetary institution of the Sverdlovsk region "Ural Research Institute of Dermatovenereology and Immunopathology", Ekaterinburg, 620076, Russian Federation|Limited Liability Company "Alliance Biomedical - Ural Group", Izhevsk, 426061, Russian Federation|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, 610027, Russian Federation|State health care institution "Regional Dermatovenerological Dispensary", Lipetsk, 398005, Russian Federation|Limited Liability Company "OLLA-MED", Moscow, 105554, Russian Federation|Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova", Moscow, 115522, Russian Federation|Limited Liability Company "Firma ORIS", Moscow, 117321, Russian Federation|State budgetary healthcare institution of the city of Moscow "Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Health Department", Moscow, 119071, Russian Federation|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, 127006, Russian Federation|State budgetary healthcare institution of the Moscow region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky", Moscow, 129110, Russian Federation|Limited Liability Company "Medical Center "Healthy Family", Novosibirsk, 630099, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia, Orenburg, 460018, Russian Federation|State budgetary institution of the Ryazan region "Regional clinical dermatovenerological dispensary", Ryazan, 390046, Russian Federation|Limited Liability Company "Medical Technologies" LLC "Medical Technologies", Saint Petersburg, 192148, Russian Federation|Limited Liability Company "Interleukin", Saint Petersburg, 194214, Russian Federation|Limited Liability Company "Research Center Eco-Safety", Saint Petersburg, 196143, Russian Federation|Limited Liability Company "ArsVite North-West", Saint Petersburg, 196191, Russian Federation|Limited Liability Company "Curator", Saint Petersburg, 196240, Russian Federation|Limited Liability Company "SB Clinic of Cosmetology", Saratov, 410012, Russian Federation|Regional state budgetary healthcare institution "Smolensk Dermatovenerological Dispensary", Smolensk, 214031, Russian Federation|State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital, Ulyanovsk, 432063, Russian Federation

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.

Primary Outcome Measures: 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 Outcome Measures: The proportion of patients achieving PASI50/75/90/100, 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 60|Time to reach PASI50, PASI75, PASI90, PASI100, 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 60|Area under the curve (AUC) of PASI, 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 60|The proportion of partial responders (ie, patients achieving ≥50% but <75% improvement in PASI compared to baseline), 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 60|Changes in the BSA index, Using the BSA (Body Surface Area) index, the surface area of the skin affected by psoriasis is assessed. BSA is measured in %. To determine the area of psoriatic skin lesions the "palm" rule is applicable. On the scalp, the affected area the size of one palm is assumed to be 10%, the torso - 3.3%, the upper extremities - 5%, the lower extremities - 2.5% of the area of the anatomical region of the body. To calculate the total BSA, each reported percentage must be multiplied by the corresponding factor of the corresponding body region (head = 0.1, torso = 0.3, upper extremities = 0.2, lower extremities = 0.4). The resulting four percentage values (percentage of skin affected by psoriasis on the scalp, upper extremities, trunk, and lower extremities) will be summed to estimate the BSA index., Week 60|Changes in PGA, The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe)., Week 60|Changes in the intensity of itching on the visual analogue scale (VAS), The intensity of itching is carried out at all visits using a visual analogue scale (VAS), where the left end of the line is 0 = no itching, the right end of the line is 10 = intense itching, Week 60|Changes in quality of life, assessed using the Dermatology Life Quality Index (DLQI), The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life)., Week 60|The proportion of patients who dropped out of the study due to lack of sufficient therapeutic response, Treatment failure is assessed as no effect within 28 weeks (PASI response \<50%), Week 60