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Study identifier: NCT07080034 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Ulcerative Colitis (UC)  ·  Sponsor: Biocad

PhasePhase 2
Planned participants198
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients with moderate to severe active ulcerative colitis. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active ulcerative colitis and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics/targeted immunosuppressants.

This description comes directly from the study's public registry record.

Talk to the study team

Anna V Gaponova  ·  +7 (812) 380 49 33  ·  gaponova@biocad.ru

Aleksey V Manziuk  ·  +7 (812) 380 49 33  ·  manziuk@biocad.ru

Always discuss trial participation with your own doctor first.

Locations (20)

LLC Medical Center "ASTRA"Barnaul, Altayskiy Kray, RussiaRecruiting
Republican Clinical Hospital named after G.G. KuvatovUfa, Bashkortostan Republic, RussiaRecruiting
Federal State Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian FederationRostov-on-Don, Rostov Oblast, RussiaRecruiting
Federal State Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian FederationRostov-on-Don, Rostov Oblast, RussiaRecruiting
State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of the Republic of Tatarstan"Kazan', Tatarstan Republic, RussiaRecruiting
"South Ural State Medical University" of the Ministry of Health of the Russian FederationChelyabinsk, RussiaRecruiting
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological AgencyKrasnoyarsk, RussiaRecruiting
Regional State Healthcare Institution "Regional Clinical Hospital"Krasnoyarsk, RussiaRecruiting
Llc "Olla-Med"Moscow, RussiaRecruiting
Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health DepartmentMoscow, RussiaRecruiting
State Healthcare Institution of the City of Moscow "V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department"Moscow, RussiaRecruiting
Branch of the LLC "Hadassah Medical LTD"Moscow, RussiaRecruiting

+ 8 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07080034