Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease

NCT07078994 | Recruiting Phase 2 DMC

• 1 other identifier: BCD-261-2
• Study Type: interventional
• Target: 204
• 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 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

Crohn's Disease (CD)

Keywords

biologics; Crohn's disease; monoclonal antibodies; TL1A

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects who achieved clinical remission

  Proportion of subjects with Crohn's Disease Activity Index (CDAI) score of \<150

  week 14

• Proportion of subjects who achieved an endoscopic response

  Proportion of subjects with ≥50% reduction Simple Endoscopic Score for Crohn's Disease (SES-CD) from the baseline

  week 14

Secondary Outcomes (1)

• Proportion of subjects who achieved clinical remission

  week 24

Other Outcomes (12)

• Proportion of subjects who achieved a clinical response

  weeks 14, 24, 52, and 100

• Proportion of subjects who achieved clinical remission

  weeks 52, 100

• Proportion of subjects who achieved clinical remission

  weeks 24, 52, and 100

Study Arms (5)

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

EXPERIMENTAL

Subjects in this arm will receive a medium dose of the BCD-261 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a low dose of the BCD-261

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

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

EXPERIMENTAL

Subjects in this arm will receive a medium dose of the BCD261 during both the induction phase (Weeks 0-12) and the maintenance regimen

Biological: anti-TL1A monoclonal antibody, medium dose

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

EXPERIMENTAL

Subjects in this arm will receive a high dose of the BCD-261 during the induction regimen (Weeks 0-12), followed by a transition to a maintenance regimen with a medium dose of the BCD-261

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

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

EXPERIMENTAL

Subjects in this arm will receive a high dose of the BCD261 during both the induction phase (Weeks 0-12) and the maintenance regimen

Biological: anti-TL1A monoclonal antibody, high dose

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo till the assessment of the primary endpoint and then will be switched to BCD-261medium studied dose

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:

• The diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3 according to the Montreal classification), established ≥3 months prior to signing the informed consent form and confirmed by endoscopic findings.
• Moderate to severe active Crohn's disease, manifested by the following signs:
• (1) Crohn's Disease Activity Index (CDAI) ≥220 and ≤450 points.
• (2) Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 points or ≥4 points for the disease form with isolated involvement of the ileum (according to central independent review).
• \. 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 and/or methotrexate at a dose of ≥15.0 mg/week) 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 targeted immunosuppressors (upadacitinib), 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 targeted immunosuppressors (upadacitinib), 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 glucocorticoid therapy and/or immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate) and/or biologic therapies (TNFα inhibitors, anti-integrins, IL-12/23 inhibitors) and/or targeted immunosuppressors (upadacitinib), as determined 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 for ≥4 weeks prior to signing the
• ICF and in the screening period for immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate).

You may not qualify if:

• A history of or current at the time of signing the ICF ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.
• A history of primary sclerosing cholangitis.
• Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.
• Presence of an endoscopically obstructed stricture/stenosis of the intestine at the time of signing the ICF.
• A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
• A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.
• Previous resections of the small intestine with a total length of resected segments \>100 cm and/or resection of \>2 segments of the large intestine (ascending colon (including the cecum), transverse colon, descending colon (including the sigmoid colon), rectum)3.
• 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, upadacitinib) or ≥4 biologics/targeted immunosuppressants (according to INN), regardless of the mechanism of actio
• Use of any of the indicated therapies within the specified time frame or need for therapy with these drugs during the study period:
• Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
• Use of anti-integrins or IL-12/23 inhibitors within 12 weeks before signing the ICF or during the screening period.
• Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to signing the ICF or during the screening period.
• 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.
• 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

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

Moscow, Moscow, 129110, Russia

RECRUITING

Llc "Novosibirsk Gastrocenter"

Novosibirsk, Novosibirsk Oblast, 630007, 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

LLC "Research Center Eco-Safety"

Saint Petersburg, Sankt-Peterburg, 196143, 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, 60037, 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

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

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

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Arina V Zinkina-Orikhan

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

Aleksey V Manziuk

CONTACT

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

Anna V Gaponova

CONTACT

gaponova@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 14, 2025
• First Posted: July 22, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (20)