Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis

PHASE2RecruitingINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

August 14, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

October 31, 2028

Conditions
Ulcerative Colitis (UC)
Interventions
BIOLOGICAL

anti-TL1A monoclonal antibody, low dose

injection

BIOLOGICAL

anti-TL1A monoclonal antibody, medium dose

injection

BIOLOGICAL

anti-TL1A monoclonal antibody, high dose

injection

OTHER

Placebo

injection

Trial Locations (20)

105554

RECRUITING

"Llc Olla-Med", Moscow

111123

RECRUITING

Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department, Moscow

115516

RECRUITING

"State Healthcare Institution of the City of Moscow V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department", Moscow

121205

RECRUITING

"Branch of the LLC Hadassah Medical LTD", Moscow

129110

RECRUITING

"State Institution of Healthcare of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirsky", Moscow

191015

RECRUITING

"Federal State Educational Institution of Higher Education North-West State Medical University named after I.I. Mechnikov of the Ministry of Health of the Russian Federation", Saint Petersburg

195257

RECRUITING

"Saint Petersburg State Healthcare Institution City Hospital of the Holy Martyr Elizabeth", Saint Petersburg

197022

RECRUITING

"Federal State Educational Institution of Higher Education First Saint Petersburg State Medical University named after Academician I.P. Pavlov of the Ministry of Health of the Russian Federation", Saint Petersburg

344022

RECRUITING

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

RECRUITING

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

420064

RECRUITING

"State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of the Republic of Tatarstan", Kazan'

432063

RECRUITING

State Healthcare Institution Ulyanovsk Regional Clinical Hospital, Ulyanovsk

450005

RECRUITING

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

454092

RECRUITING

"South Ural State Medical University of the Ministry of Health of the Russian Federation", Chelyabinsk

630007

RECRUITING

"Llc Novosibirsk Gastrocenter", Novosibirsk

656049

RECRUITING

"LLC Medical Center ASTRA", Barnaul

660022

RECRUITING

Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk

RECRUITING

"Regional State Healthcare Institution Regional Clinical Hospital", Krasnoyarsk

690091

RECRUITING

"State Healthcare Institution Primorsky Regional Clinical Hospital No. 1", Vladivostok

Unknown

RECRUITING

"LLC Research Center Eco-Safety", Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY