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BCD-261 treatment for moderate to severe ulcerative colitis

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 Ulcerative Colitis

Phase 2 Interventional Biocad · NCT07080034

This trial tests whether different doses of BCD-261, an anti‑TL1A monoclonal antibody, can improve symptoms and inflammation in adults 18–75 with moderate to severe ulcerative colitis who have not responded to steroids, immunosuppressants, or biologics.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment198 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiocad Industry-sponsored
Drugs / interventionsradiation, prednisone
Locations20 sites (Barnaul, Altayskiy Kray and 19 other locations)
Trial IDNCT07080034 on ClinicalTrials.gov

What this trial studies

This phase 2, randomized, placebo‑controlled trial assigns eligible adults to one of five groups to receive low, medium, or high doses of BCD‑261 or placebo, with placebo participants switched to the medium dose after the primary endpoint. The protocol includes induction and maintenance treatment periods and centrally reviewed endoscopy for entry criteria. Outcomes include clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity, with a specific focus on defining the dose–response relationship. Results will inform dose selection for later‑phase studies.

Who should consider this trial

Good fit: Adults 18–75 with moderate to severe active ulcerative colitis (modified Mayo score 4–9 with endoscopic activity) and an inadequate response to glucocorticoids, immunosuppressants, or biologics are the intended participants.

Not a fit: People with mild disease, those outside the 18–75 age range, or those who are doing well on existing treatments are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, BCD-261 could provide a new biologic option to reduce inflammation and improve symptoms for patients who have failed current therapies.

How similar studies have performed: Early‑phase work on TL1A‑targeting antibodies in inflammatory bowel disease has shown preliminary signals of efficacy, but larger confirmatory trials remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1\. 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.

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:

1. 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.
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.

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 Ulcerative Colitisbiologicsulcerative colitismonoclonal antibodiesTL1A
Last reviewed 2026-06-09 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.