Actively Recruiting
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
Led by Biocad · Updated on 2025-09-17
204
Participants Needed
20
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the study drug BCD-261 in patients with moderate to severe active Crohn's Disease. This study involves adult men and women aged 18 to 75 years who have had an inadequate response to previous treatments such as glucocorticoids, immunosuppressants, or biologics. The trial is designed to better understand the dose-response relationship of BCD-261 compared to a placebo in this patient group. Participants are randomly assigned to one of five groups receiving different dosing regimens of BCD-261 or placebo. Four groups receive varying doses of BCD-261 (low, medium, high) during induction (weeks 0-12) and maintenance phases, with some groups transitioning between doses. The fifth group receives placebo until the primary endpoint assessment at week 14, after which they switch to the medium dose of BCD-261. During the study, participants will be closely monitored for clinical remission and endoscopic response at week 14, with additional remission assessments at week 24. The study includes comprehensive evaluations such as safety monitoring and pharmacokinetic and pharmacodynamic assessments. Participants will be involved throughout the induction and maintenance periods with scheduled visits and assessments to track treatment effects and safety over time.
CONDITIONS
Brief 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...
- Diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3) confirmed by endoscopy and established at least 3 months before consent.
- Moderate to severe active Crohn's disease with Crohn's Disease Activity Index (CDAI) between 220 and 450 and Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 6 or 4 for isolated ileum involvement.
- Inadequate response to prior therapy shown by persistent symptoms despite glucocorticoids, steroid dependence, inadequate response or intolerance to immunosuppressants or biologics.
- Stable doses of glucocorticoids for at least 2 weeks and immunosuppressants for at least 4 weeks before consent and during screening.
- Age between 18 and 75 years.
You will not qualify if you...
- History or current ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, or complicated diverticular disease.
- History of primary sclerosing cholangitis.
- Presence of active intra-abdominal or perianal abscess.
- Presence of endoscopically obstructed intestinal stricture or stenosis.
- History of toxic megacolon, intestinal obstruction, or intestinal perforation not caused by injury or appendicitis.
- History of dysplasia in the gastrointestinal tract.
- Previous resection of more than 100 cm of small intestine or more than 2 segments of the large intestine.
- Presence or need for intestinal stoma or artificial rectum.
- Failure of 3 or more biologics/targeted immunosuppressors with different mechanisms, or 4 or more biologics regardless of mechanism.
- Use of specified biologics or immunosuppressive drugs within defined timeframes before consent.
- Use of oral glucocorticoids above specified doses or routes within defined timeframes before consent.
- Use of immunosuppressants not approved in the study within 4 weeks before consent.
- Long-term regular use of NSAIDs (3 or more times a week for 6 weeks) within 2 weeks before consent.
- Use of other investigational drugs within 8 weeks or 5 half-lives before consent or during screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants are randomized to receive one of four dosage regimens of BCD-261 or placebo. The treatment includes an induction phase (Weeks 0-12) followed by a maintenance phase with varying doses of BCD-261 depending on the group. Participants in the placebo group switch to a medium dose of BCD-261 after the primary endpoint assessment at Week 14.
Regular visits during induction and maintenance phases
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
A
Anna V Gaponova
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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