Actively Recruiting
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
Led by Biocad · Updated on 2025-09-17
204
Participants Needed
20
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed Crohn's disease involving the terminal ileum or colon for at least 3 months, confirmed by endoscopy
- Moderate to severe active Crohn's disease with Crohn's Disease Activity Index (CDAI) between 220 and 450
- Simple Endoscopic Score for Crohn's Disease (SES-CD) of 6 or higher, or 4 or higher if only the ileum is affected
- Inadequate response to prior treatments including glucocorticoids, immunosuppressants, or biologics/targeted immunosuppressors based on specified criteria
- Stable doses of glucocorticoids for at least 2 weeks and immunosuppressants for at least 4 weeks before screening
- Age between 18 and 75 years
You will not qualify if you...
- History or current diagnosis of ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, or complicated diverticular disease
- History of primary sclerosing cholangitis
- Active intra-abdominal or perianal abscess
- Endoscopically obstructed intestinal stricture or stenosis
- History of toxic megacolon, intestinal obstruction, or intestinal perforation (except trauma or appendicitis)
- History of gastrointestinal dysplasia
- Previous extensive small intestine or multiple large intestine resections exceeding specified lengths
- Presence of intestinal stoma, artificial rectum, or need for these
- Failure of three or more classes of biologics/targeted immunosuppressors or four or more biologics regardless of mechanism
- Use of certain biologics, Janus kinase inhibitors, high-dose steroids, non-approved immunosuppressants, long-term NSAIDs, or investigational drugs within specified recent timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
LLC Medical Center "ASTRA"
Barnaul, Altayskiy Kray, Russia, 656049
Actively Recruiting
2
Republican Clinical Hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, Russia, 450005
Actively Recruiting
3
State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
Moscow, Moscow, Russia, 129110
Actively Recruiting
4
Llc "Novosibirsk Gastrocenter"
Novosibirsk, Novosibirsk Oblast, Russia, 630007
Actively Recruiting
5
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, 344022
Actively Recruiting
6
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, 344022
Actively Recruiting
7
LLC "Research Center Eco-Safety"
Saint Petersburg, Sankt-Peterburg, Russia, 196143
Actively Recruiting
8
State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of the Republic of Tatarstan"
Kazan', Tatarstan Republic, Russia, 420064
Actively Recruiting
9
"South Ural State Medical University" of the Ministry of Health of the Russian Federation
Chelyabinsk, Russia, 454092
Actively Recruiting
10
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Russia, 60037
Actively Recruiting
11
Regional State Healthcare Institution "Regional Clinical Hospital
Krasnoyarsk, Russia, 660022
Actively Recruiting
12
Llc "Olla-Med"
Moscow, Russia, 105554
Actively Recruiting
13
Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department
Moscow, Russia, 111123
Actively Recruiting
14
State Healthcare Institution of the City of Moscow "V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department"
Moscow, Russia, 115516
Actively Recruiting
15
Branch of the LLC "Hadassah Medical LTD"
Moscow, Russia, 121205
Actively Recruiting
16
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, 191015
Actively Recruiting
17
Saint Petersburg State Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
Saint Petersburg, Russia, 195257
Actively Recruiting
18
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, 197022
Actively Recruiting
19
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russia, 432063
Actively Recruiting
20
State Healthcare Institution "Primorsky Regional Clinical Hospital No. 1"
Vladivostok, Russia, 690091
Actively Recruiting
Research Team
A
Aleksey V Manziuk
CONTACT
A
Anna V Gaponova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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