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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

July 25, 2023

Primary Completion Date

April 30, 2025

Study Completion Date

September 30, 2025

Conditions
Plaque Psoriasis
Interventions
BIOLOGICAL

GNR-068

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

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.

Trial Locations (34)

105554

"Limited Liability Company OLLA-MED", Moscow

115522

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

117321

"Limited Liability Company Firma ORIS", Moscow

119071

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

127006

"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

129110

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

141060

"Limited Liability Company Family Clinic No. 4", Korolyov

188678

"Limited Liability Company Available Polyclinic", Murino

191123

"Limited Liability Company Clinic of Skin Diseases Pierre Wolkenstein", Saint Petersburg

"Limited Liability Company International Medical Center", Saint Petersburg

192148

"Limited Liability Company Medical Technologies LLC Medical Technologies", Saint Petersburg

194156

"Limited Liability Company Health Energy", Saint Petersburg

194214

"Limited Liability Company Interleukin", Saint Petersburg

196084

"Limited Liability Company Institute of Medical Research", Saint Petersburg

196143

"Limited Liability Company Research Center Eco-Safety", Saint Petersburg

196158

"Limited Liability Company PiterKlinika", Saint Petersburg

196191

"Limited Liability Company ArsVite North-West", Saint Petersburg

196240

"Limited Liability Company Curator", Saint Petersburg

196603

"Private medical institution Euromedservice", Saint Petersburg

197136

"Limited Liability Company MEDINET", Saint Petersburg

214031

"Regional state budgetary healthcare institution Smolensk Dermatovenerological Dispensary", Smolensk

390046

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

398005

"State health care institution Regional Dermatovenerological Dispensary", Lipetsk

410012

"Limited Liability Company SB Clinic of Cosmetology", Saratov

420111

"Limited Liability Company Medical Center Azbuka Health", Kazan'

426061

"Limited Liability Company Alliance Biomedical - Ural Group", Izhevsk

432063

State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital, Ulyanovsk

454048

"State budgetary healthcare institution Chelyabinsk Regional Clinical Dermatovenerological Dispensary", Chelyabinsk

454126

"Limited Liability Company Ecology of Health", Chelyabinsk

460018

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

610027

"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

620076

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

630099

"Limited Liability Company Medical Center Healthy Family", Novosibirsk

656038

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

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY