Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT07080034 | Recruiting Phase 2 DMC

• 1 other identifier: BCD-261-4
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 20

Brief 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 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

Ulcerative Colitis (UC)

Keywords

biologics; ulcerative colitis; monoclonal antibodies; TL1A

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieved clinical remission

  Proportion of subjects with modified Mayo score ≤2 points (endoscopic mucosal score ≤1, stool blood score = 0, stool frequency score ≤1, assessment for each component should not exceed the baseline level)

  week 14

Secondary Outcomes (1)

• Proportion of subjects who achieved clinical remission

  week 24

Other Outcomes (14)

• Proportion of subjects who achieved a clinical response

  weeks 14, 24, 52, 100

• Proportion of subjects who achieved clinical remission

  weeks 52, 100

• Proportion of subjects who achieved clinical remission

  weeks 24, 52, 100

Study Arms (5)

BCD-261, medium dose induction/ low dose maintenance regimens

EXPERIMENTAL

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.

Biological: anti-TL1A monoclonal antibody, low dose; Biological: anti-TL1A monoclonal antibody, medium dose

BCD-261, medium dose induction/ medium dose maintenance regimens

EXPERIMENTAL

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.

Biological: anti-TL1A monoclonal antibody, medium dose

BCD-261, high dose induction/ medium dose maintenance regimens

EXPERIMENTAL

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.

Biological: anti-TL1A monoclonal antibody, medium dose; Biological: anti-TL1A monoclonal antibody, high dose

BCD-261, high dose induction/ high dose maintenance regimens

EXPERIMENTAL

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.

Biological: anti-TL1A monoclonal antibody, high dose

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

anti-TL1A monoclonal antibody, low dose BIOLOGICAL

injection

BCD-261, medium dose induction/ low dose maintenance regimens

anti-TL1A monoclonal antibody, medium dose BIOLOGICAL

injection

BCD-261, high dose induction/ medium dose maintenance regimens; BCD-261, medium dose induction/ low dose maintenance regimens; BCD-261, medium dose induction/ medium dose maintenance regimens

anti-TL1A monoclonal antibody, high dose BIOLOGICAL

injection

BCD-261, high dose induction/ high dose maintenance regimens; BCD-261, high dose induction/ medium dose maintenance regimens

Placebo OTHER

injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosis of ulcerative colitis with involvement of the colon proximal to the rectum (≥15 cm from the distal edge of the anal canal), established ≥3 months before signing the ICF and confirmed by endoscopic examination data.
• \. 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.
• \. Inadequate response to therapy according to the investigator's assessment, manifested by at least one of the following signs:
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• \. 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).

You may not qualify if:

• A history of or current at the time of signing the ICF Crohn's disease, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.
• A history of primary sclerosing cholangitis.
• A history of fulminant colitis, toxic dilation of the colon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
• A history of dysplasia of any grade in any part of the gastrointestinal tract at the time of signing the ICF.
• Presence of intestinal stoma or artificial rectum or the need for them.
• 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.
• 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
• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (20)

LLC Medical Center "ASTRA"

Barnaul, Altayskiy Kray, 656049, Russia

RECRUITING

Republican Clinical Hospital named after G.G. Kuvatov

Ufa, Bashkortostan Republic, 450005, Russia

RECRUITING

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, 344022, Russia

RECRUITING

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, 344022, Russia

RECRUITING

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

Kazan', Tatarstan Republic, 420064, Russia

RECRUITING

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

Chelyabinsk, 454092, Russia

RECRUITING

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

Krasnoyarsk, 660022, Russia

RECRUITING

Regional State Healthcare Institution "Regional Clinical Hospital"

Krasnoyarsk, 660022, Russia

RECRUITING

Llc "Olla-Med"

Moscow, 105554, Russia

RECRUITING

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

Moscow, 111123, Russia

RECRUITING

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

Moscow, 115516, Russia

RECRUITING

Branch of the LLC "Hadassah Medical LTD"

Moscow, 121205, Russia

RECRUITING

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

Moscow, 129110, Russia

RECRUITING

Llc "Novosibirsk Gastrocenter"

Novosibirsk, 630007, Russia

RECRUITING

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, 191015, Russia

RECRUITING

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

Saint Petersburg, 195257, Russia

RECRUITING

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, 197022, Russia

RECRUITING

LLC "Research Center Eco-Safety"

Saint Petersburg, Russia

RECRUITING

State Healthcare Institution Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

RECRUITING

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

Vladivostok, 690091, Russia

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Arina V Zinkina-Orikhan

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

Anna V Gaponova

CONTACT

+7 (812) 380 49 33; gaponova@biocad.ru

Aleksey V Manziuk

CONTACT

+7 (812) 380 49 33; manziuk@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (20)