Actively Recruiting
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
Led by Biocad · Updated on 2025-09-19
198
Participants Needed
20
Research Sites
163 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 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.
CONDITIONS
Official Title
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis involving at least 15 cm from the distal anal canal, confirmed by endoscopy at least 3 months before consent
- Moderate to severe active ulcerative colitis with a modified Mayo score between 4 and 9, including endoscopic score of 2 or more and stool blood score of 1 or more
- Inadequate response to treatment defined by persistent symptoms despite steroids, steroid dependence, inadequate response to immunosuppressants, lack or loss of response to biologics/targeted immunosuppressants, or intolerance to these therapies
- Stable doses of glucocorticoids and 5-aminosalicylic acids for at least 2 weeks and immunosuppressants for at least 4 weeks before consent and during screening
You will not qualify if you...
- History or current diagnosis of Crohn's disease, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, or complicated diverticular disease
- History of primary sclerosing cholangitis
- History of fulminant colitis, toxic colon dilation, bowel obstruction, or perforation (except injury or appendicitis related)
- History of gastrointestinal dysplasia of any grade
- Presence or need for intestinal stoma or artificial rectum
- Failure of three or more classes of biologics/targeted immunosuppressants or four or more biologics regardless of mechanism
- Use of specified drugs within restricted time frames before consent including Janus kinase inhibitors, TNF-alpha inhibitors, sphingosine-1-phosphate receptor modulators, anti-integrins, IL-12/23 inhibitors, or high dose glucocorticoids
- Use of rectal 5-aminosalicylic acids or unapproved immunosuppressants within specified windows
- Long-term regular use of NSAIDs (three or more times per week for six weeks) within two weeks prior to consent
- Participation in other investigational drug trials within eight weeks or five half-lives before randomization
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
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
4
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
5
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
6
"South Ural State Medical University" of the Ministry of Health of the Russian Federation
Chelyabinsk, Russia, 454092
Actively Recruiting
7
Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Russia, 660022
Actively Recruiting
8
Regional State Healthcare Institution "Regional Clinical Hospital"
Krasnoyarsk, Russia, 660022
Actively Recruiting
9
Llc "Olla-Med"
Moscow, Russia, 105554
Actively Recruiting
10
Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department
Moscow, Russia, 111123
Actively Recruiting
11
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
12
Branch of the LLC "Hadassah Medical LTD"
Moscow, Russia, 121205
Actively Recruiting
13
State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
Moscow, Russia, 129110
Actively Recruiting
14
Llc "Novosibirsk Gastrocenter"
Novosibirsk, Russia, 630007
Actively Recruiting
15
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
16
Saint Petersburg State Healthcare Institution "City Hospital of the Holy Martyr Elizabeth"
Saint Petersburg, Russia, 195257
Actively Recruiting
17
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
18
LLC "Research Center Eco-Safety"
Saint Petersburg, Russia
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
Anna V Gaponova
CONTACT
A
Aleksey V Manziuk
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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