An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

May 29, 2025

Study Completion Date

July 10, 2025

Conditions
Still's Disease Adult Onset
Interventions
BIOLOGICAL

GNR-086

GNR-086 is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.

BIOLOGICAL

Ilaris®

Ilaris® is administered as a subcutaneous injection at a dose of 4 mg/kg once every 4 weeks for 24 weeks.

Trial Locations (17)

105554

Limited Liability Company "OLLA-MED", Moscow

115522

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

123182

State budgetary healthcare institution of the city of Moscow "City Clinical Hospital No. 52 of the Moscow Health Department" (GBUZ "City Clinical Hospital No. 52 DZM"), Moscow

129226

Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N. I. Pirogova, Moscow

"Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N.I. Pirogov Ministry of Health of Russia Separate structural unit Russian Gerontological Scientific and Clinical Center", Moscow

150030

"State Budgetary Healthcare Institution Clinical Hospital No. 2", Yaroslavl

192148

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

194156

Limited Liability Company "Ex Seven Clinical Research", Saint Petersburg

194214

Limited Liability Company "Interleukin", Saint Petersburg

194291

State Budgetary Healthcare Institution Leningrad area Clinical Hospital, Saint Petersburg

214025

Private foundation "RZD-Medicine" Smolensk", Smolensk

400138

State health care institution city clinical hospital №25, Volgograd

454076

State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital", Chelyabinsk

460018

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

600005

Limited Liability Company "BioMed", Vladimir

630099

Limited Liability Company "Medical Center "Healthy Family", Novosibirsk

650070

Limited Liability Company "Medical Center "Revma-Med", Kemerovo

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT06497491 - An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease | Biotech Hunter | Biotech Hunter