Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
NCT ID: NCT07080034
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
198 participants
INTERVENTIONAL
2025-08-14
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BCD-261, medium dose induction/ low dose maintenance regimens
Group 1: Subjects in this arm will receive a medium dose of the BCD-261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a low dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.
anti-TL1A monoclonal antibody, low dose
injection
anti-TL1A monoclonal antibody, medium dose
injection
BCD-261, medium dose induction/ medium dose maintenance regimens
Group 2: Subjects in this arm will receive a medium dose of the BCD261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by the maintenance regimen with the same dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.
anti-TL1A monoclonal antibody, medium dose
injection
BCD-261, high dose induction/ medium dose maintenance regimens
Group 3: Subjects in this arm will receive a high dose of the BCD-261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12) , followed by a transition to a maintenance regimen with a medium dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.
anti-TL1A monoclonal antibody, medium dose
injection
anti-TL1A monoclonal antibody, high dose
injection
BCD-261, high dose induction/ high dose maintenance regimens
Group 4: Subjects in this arm will receive a high dose of the BCD261 subcutaneously once every 4 weeks until Week 12 during the induction regimen (Weeks 0-12), followed by maintenance regimen with with the same dose of the BCD-261 once every 8 weeks from Week 20 to Week 100.
anti-TL1A monoclonal antibody, high dose
injection
Placebo
Group 5: Subjects in this arm will receive placebo subcutaneously at Weeks 0, 4, 8, and 12, followed by a medium dose of the BCD-261 subcutaneously once every 4 weeks until Week 28 , followed by a transition to a low dose of the BCD-261 once every 8 weeks from Week 36 to Week 100.
Placebo
injection
Interventions
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anti-TL1A monoclonal antibody, low dose
injection
anti-TL1A monoclonal antibody, medium dose
injection
anti-TL1A monoclonal antibody, high dose
injection
Placebo
injection
Eligibility Criteria
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Inclusion Criteria
2\. Moderate to severe active ulcerative colitis with a modified Mayo score (mMS) of ≥4 and ≤9 points, which includes an endoscopic component of ≥2 points (according to a central independent review) and a stool blood score of ≥1 point.
3\. Inadequate response to therapy according to the investigator's assessment, manifested by at least one of the following signs:
1. Persistent symptoms of disease activity despite treatment with at least one course of glucocorticoids including prednisolone at a dose of ≥40 mg/day or equivalent or budesonide ≥9 mg/day or equivalent for at least 2 weeks with oral administration (at least 1 week with intravenous administration at a dose equivalent to oral prednisolone ≥40 mg/day).
2. Steroid dependence manifested by an increase in disease activity after initial improvement, with a decrease in the dose of glucocorticoids below the dose equivalent to 10 mg of oral prednisolone per day, within 3 months from the beginning of treatment, or a relapse of the disease within 3 months after the end of glucocorticoid use.
3. Persistent symptoms of disease activity despite treatment with at least one course of immunosuppressants (azathioprine at a dose of ≥2.0 mg/kg and/or 6-mercaptopurine at a dose of ≥1.0 mg/kg) for ≥12 weeks, or in response to another treatment regimen with these drugs according to a regional standard of care.
4. Primary lack of response to therapy with TNFa inhibitors and/or anti-integrins, and/or IL-12/23 inhibitors, and/or Janus kinase inhibitors, and/or sphingosine-1-phosphate receptor modulators, defined as the persistence of symptoms of disease activity despite at least one course of induction of remission according to a treatment scheme approved by the regional standard.
5. Loss of response to therapy with TNFa inhibitors and/or anti-integrins, and/or IL-12/23 inhibitors, and/or Janus kinase inhibitors, and/or sphingosine-1-phosphate receptor modulators, defined as the appearance of symptoms of disease activity after initial improvement as a result of treatment with at least one course of induction of remission and at least one course of maintenance of remission according to a treatment scheme approved by the regional standard.
6. A history of intolerance to glucocorticoids and/or immunosuppressants (azathioprine, 6-mercaptopurine) and/or biological therapy/targeted immunosuppressants (TNFa inhibitors, anti-integrins, anti-IL-12/23 monoclonal antibodies, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators) established by the treating physician.
4\. Maintaining a stable dose of concomitant medications for ≥2 weeks prior to signing the ICF and in the screening period for glucocorticoids and 5-ASCs and for ≥4 weeks prior to signing the ICF and in the screening period for immunosuppressants (azathioprine, 6-mercaptopurine).
Exclusion Criteria
2. A history of primary sclerosing cholangitis.
3. A history of fulminant colitis, toxic dilation of the colon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
4. A history of dysplasia of any grade in any part of the gastrointestinal tract at the time of signing the ICF.
5. Presence of intestinal stoma or artificial rectum or the need for them.
6. Failure of ≥3 classes of biologics/targeted immunosuppressors (according to INN) with different mechanisms of action (TNFa inhibitors, anti-integrins, IL-12/23 inhibitors, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators) or ≥4 biologics/targeted immunosuppressants, regardless of the mechanism of action.
7. Use of any of the indicated therapies within the specified time frame or need for therapy with these drugs during the study period:
(1) Use of Janus kinase inhibitors within 2 weeks prior to signing the ICF or during the screening period.
(2) Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
(3) Using modulators of sphingosine-1-phosphate receptors within 10 weeks prior to signing the ICF or during the screening period.
(4) Use of anti-integrins, IL-12/23 inhibitors within 12 weeks before signing the ICF or during the screening period.
(5) Use of oral glucocorticoids at a dose equivalent to prednisone \>20 mg/day or budesonide \>9 mg/day or rectal administration of glucocorticoids at any dose within
2 weeks prior to signing the ICF or during the screening period or parenteral administration of glucocorticoids at any dose within 4 weeks prior to signing the ICF or during the screening period.
(6) Rectal administration of 5-ASCs within 2 weeks prior to signing the ICF or during the screening period.
(7) Use of immunosuppressants not included in the approved therapy (tacrolimus, cyclosporine, mycophenolate mofetil, rapamycin, leflunomide, penicillamine, etc.) within 4 weeks before signing the ICF or during the screening period.
(8) Long-term regular use of non-steroidal anti-inflammatory drugs (≥3 times a week for ≥6 weeks) for 2 weeks prior to signing the ICF.
(9) Use of any other investigational drugs in other clinical trials at the time of signing the ICF or less than 8 weeks or 5 half-lives (whichever is longer) before the date of randomization.
18 Years
75 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Arina V Zinkina-Orikhan
Role: STUDY_DIRECTOR
Director of Clinical Development Department, BIOCAD
Locations
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LLC Medical Center "ASTRA"
Barnaul, Altayskiy Kray, Russia
Republican Clinical Hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, 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
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
State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
Moscow, , Russia
Llc "Novosibirsk Gastrocenter"
Novosibirsk, , 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
LLC "Research Center Eco-Safety"
Saint Petersburg, , Russia
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , Russia
State Healthcare Institution "Primorsky Regional Clinical Hospital No. 1"
Vladivostok, , Russia
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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BCD-261-4
Identifier Type: -
Identifier Source: org_study_id
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