RecruitingPhase 2NCT07078994

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

A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease

Sponsor

Biocad

Enrollment

204 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease (CD)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new biologic drug called BCD-261 for people with moderate to severe Crohn's disease — a chronic inflammatory bowel condition — whose symptoms have not been well controlled by other treatments including steroids, immunosuppressants, or other biologic drugs. **You may be eligible if...** - You have been diagnosed with Crohn's disease for at least 3 months, confirmed by endoscopy - Your disease is moderately to severely active - Previous treatments (such as steroids or other immune-suppressing drugs) have not worked well or have caused intolerable side effects **You may NOT be eligible if...** - You have ulcerative colitis, radiation colitis, or certain other bowel conditions - You have an active abscess, bowel obstruction, or intestinal perforation - You have had major bowel surgery removing large sections of intestine - You have already failed three or more classes of biologic or targeted therapies - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALanti-TL1A monoclonal antibody, low dose

injection

BIOLOGICALanti-TL1A monoclonal antibody, medium dose

injection

BIOLOGICALanti-TL1A monoclonal antibody, high dose

injection

OTHERPlacebo

injection

Locations(20)

LLC Medical Center "ASTRA"

Barnaul, Altayskiy Kray, Russia

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, Bashkortostan Republic, Russia

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

Moscow, Moscow, Russia

Llc "Novosibirsk Gastrocenter"

Novosibirsk, Novosibirsk Oblast, Russia

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

Rostov-on-Don, Rostov Oblast, Russia

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

Rostov-on-Don, Rostov Oblast, Russia

LLC "Research Center Eco-Safety"

Saint Petersburg, Sankt-Peterburg, Russia

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

Kazan', Tatarstan Republic, Russia

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

Chelyabinsk, Russia

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

Krasnoyarsk, Russia

Regional State Healthcare Institution "Regional Clinical Hospital

Krasnoyarsk, Russia

Llc "Olla-Med"

Moscow, Russia

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

Moscow, Russia

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

Moscow, Russia

Branch of the LLC "Hadassah Medical LTD"

Moscow, Russia

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, Russia

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

Saint Petersburg, Russia

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, Russia

State Healthcare Institution Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russia

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

Vladivostok, Russia

View Full Details on ClinicalTrials.gov

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NCT07078994