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BCD-261 (anti‑TL1A) treatment for adults with moderate to severe Crohn's disease testing several dose regimens

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

Phase 2 Interventional Biocad · NCT07078994

This trial will test whether different doses of the anti‑TL1A antibody BCD-261 help adults with moderate to severe Crohn's disease who have not responded to steroids, immunosuppressants, or biologics.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiocad Industry-sponsored
Drugs / interventionsupadacitinib, radiation, methotrexate, prednisone
Locations20 sites (Barnaul, Altayskiy Kray and 19 other locations)
Trial IDNCT07078994 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with moderate to severe active Crohn's disease and inadequate response to prior therapies are randomized into five groups to receive one of four BCD-261 dose regimens or placebo. The protocol includes induction and maintenance periods with differing low, medium, and high doses, and placebo participants are switched to the medium dose after the primary endpoint assessment. The study measures clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity, and characterizes the dose–response relationship. Central endoscopic scoring and CDAI criteria are used for eligibility and outcome evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with endoscopically confirmed moderate to severe Crohn's disease (CDAI 220–450 and SES‑CD ≥6 or ≥4 for isolated ileal disease) and an inadequate response to glucocorticoids, immunosuppressants, or biologics.

Not a fit: Patients with mild Crohn's disease, disease limited outside the terminal ileum/colon, recent major surgery, known contraindications to monoclonal antibodies, or those outside the 18–75 age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BCD-261 could offer a new therapeutic option that reduces disease activity or induces remission in patients with Crohn's disease who have failed other treatments.

How similar studies have performed: Targeting TL1A is a relatively new approach in inflammatory bowel disease with some encouraging early‑phase data but limited evidence from large late‑phase trials to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. 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).

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 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.
4. 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.
5. 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.
6. 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.

4\. 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).

Exclusion Criteria:

1. 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.
2. A history of primary sclerosing cholangitis.
3. Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.
4. Presence of an endoscopically obstructed stricture/stenosis of the intestine at the time of signing the ICF.
5. A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
6. A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.
7. 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.
8. Presence of intestinal stoma or artificial rectum or the need for them.
9. 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:

     1. Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
     2. Use of anti-integrins or IL-12/23 inhibitors within 12 weeks before signing the ICF or during the screening period.
     3. Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to signing the ICF or during the screening period.
     4. 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.
     5. 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.
     6. 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.
     7. 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 signing the ICF or during screening.

Where this trial is running

Barnaul, Altayskiy Kray and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseasebiologicsCrohn's diseasemonoclonal antibodiesTL1A
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.