Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

December 25, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

February 29, 2028

Conditions
Axial Spondyloarthritis
Interventions
BIOLOGICAL

anti-TRBV9 monoclonal antibody infusions

infusions

OTHER

Placebo infusions

infusions

DRUG

Adalimumab subcutaneous injection

subcutaneous injection

OTHER

Placebo subcutaneous injection

subcutaneous injection

Trial Locations (32)

Unknown

1St City Clinical Hospital, Minsk, Minsk

"State Institution Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology", Minsk

"KGBU City Hospital No. 4 named after N.P. Gull, Barnaul", Barnaul

Chelyabinsk Regional Clinical hospital, Chelyabinsk

"Regional State Budgetary Healthcare Institution Irkutsk City Clinical Hospital 1", Irkutsk

Republican Clinical Diagnostic Center of the Ministry of Health of the Udmurt Republic, Izhevsk

Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan, Kazan'

"State Autonomous Healthcare Institution Kuzbass Clinical Emergency Hospital named after M. A. Podgorbunsky", Kemerovo

"Federal State Budgetary Institution Pirogov National Medical Surgical Center of the Ministry of Health of the Russian Federation", Moscow

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

"State Budgetary Healthcare Institution of Moscow City City Clinical Hospital 15 named after O.M. Filatov of the Moscow City Health Department", Moscow

State Budgetary Healthcare Institution of Moscow City Clinical Hospital 1 named after N.I. Pirogov of the Moscow City Health Department, Moscow

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, Moscow

"State Budgetary Healthcare Institution Center of Allergology and Immunology of Kabardino-Balkarian Republic", Nal'chik

"State Budgetary Healthcare Institution of the Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko", Nizhny Novgorod

"Federal State Budgetary Scientific Institution Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences", Novosibirsk

"Budgetary healthcare institution of the Omsk region Regional clinical hospital", Omsk

"State Budgetary Healthcare Institution of Perm Krai Order of Honour Perm Regional Clinical Hospital ", Perm

"Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation", Rostov-on-Don

Clinical Rheumatology Hospital №25, Saint Petersburg

"Federal State Budgetary Educational Institution of Higher Education St. Petersburg State University", Saint Petersburg

"Federal State Budgetary Institution Almazov National Medical Research Center of the Ministry of Health of the Russian Federation", Saint Petersburg

North-Western State Medical University n.a. I.I.Mechnikov, Saint Petersburg

"State Budgetary Healthcare Institution Samara Regional Clinical Hospital named after V.D. Seredavin", Samara

"Private Healthcare Institution Clinical Hospital RD-Medicine of the city of Saratov", Saratov

"Private Healthcare Institution Clinical Hospital RD-Medicine of Smolensk", Smolensk

"Federal State Budgetary Educational Institution of Higher Education Siberian State Medical University", Tomsk

Republican Clinical Hospital named after G. G. Kuvatov, Ufa

State Healthcare Institution Ulyanovsk Regional Clinical Hospital, Ulyanovsk

"State Healthcare Institution City Clinical Emergency Hospital 25", Volgograd

"State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital named after N.A. Semashko", Yaroslavl

"State Autonomous Healthcare Institution of the Sverdlovsk Region City Clinical Hospital 14 Ekaterinburg", Yekaterinburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT06333210 - Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) | Biotech Hunter | Biotech Hunter