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Study identifier: NCT07078994 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease

Condition: Crohn's Disease (CD)  ·  Sponsor: Biocad

PhasePhase 2
Planned participants204
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 Crohn's Disease. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active Crohn's Disease 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

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

Anna V Gaponova  ·  gaponova@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
State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"Moscow, Moscow, RussiaRecruiting
Llc "Novosibirsk Gastrocenter"Novosibirsk, Novosibirsk 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
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
LLC "Research Center Eco-Safety"Saint Petersburg, Sankt-Peterburg, 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 HospitalKrasnoyarsk, RussiaRecruiting
Llc "Olla-Med"Moscow, RussiaRecruiting

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

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Source record: clinicaltrials.gov/study/NCT07078994