A Phase 2 interventional study of anti-TL1A monoclonal antibody, low dose and anti-TL1A monoclonal antibody, medium dose in Ulcerative Colitis (UC), sponsored by Biocad. Recruiting at 20 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Biocad · Phase 2, Interventional, and Treatment
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.
Subjects meeting the eligibility criteria will be randomized in 5 groups to receive one of four studied dosage regimens of BCD-261 or placebo. The study groups will differ in drug dosages of BCD-261 (low, medium, high) during the induction and maintenance periods of therapy. After the primary endpoint assessment subjects in placebo group will be switched to BCD-261 medium studied dose.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 198 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Biocad is the lead sponsor of 94 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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) 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 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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injection
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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)
Time frame: week 14
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)
Time frame: week 24
Proportion of subjects who achieved a clinical response
Proportion of subjects modified Mayo score of ≥2 points and ≥30% from the baseline with a decrease in the estimated stool blood score of ≥1 point from the baseline or the estimated stool blood score of ≤1 point)
Time frame: weeks 14, 24, 52, 100
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)
Time frame: weeks 52, 100
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) among subjects who had a clinical response according to the modified Mayo score at Week 14
Time frame: weeks 24, 52, 100
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) without the use of glucocorticoids (for at least 12 weeks) among subjects who initially received glucocorticoid therapy
Time frame: weeks 52, 60, 100
Proportion of subjects who achieved clinical remission
Proportion of subjects with Mayo score of ≤2 (each component of the score ≤1, but not higher than the baseline)
Time frame: weeks 14, 24, 52, 100
Proportion of subjects who achieved an endoscopic response
Proportion of subjects with mucosal state assessment according to the Mayo endoscopic score of ≤1 without friability. Mayo Endoscopic Score (MES) is a widely used tool for assesing the stage of ulcerative colitis based solely on endoscopic examination. MES may vary from 0 to 3, where 0 corresponds to normal or inactive, 1 - to mild, 2- to moderate and 3 - to severe disease activity.
Time frame: weeks 14, 24, 52, 100
Proportion of subjects who achieved endoscopic remission (mucosal healing)
Proportion of subjects with a Mayo endoscopic score of 0. Mayo Endoscopic Score (MES) is a widely used tool for assesing the stage of ulcerative colitis based solely on endoscopic examination. MES may vary from 0 to 3, where 0 corresponds to normal or inactive, 1 - to mild, 2- to moderate and 3 - to severe disease activity.
Time frame: weeks 14, 24, 52, 100
Proportion of subjects who achieved an endoscopic and histological response
Proportion of subjects with Mayo endoscopic score of ≤1 without friability in combination with a Geboes score ≤3.1. Mayo Endoscopic Score (MES) is a widely used tool for assesing the stage of ulcerative colitis based solely on endoscopic examination. MES may vary from 0 to 3, where 0 corresponds to normal or inactive, 1 - to mild, 2- to moderate and 3 - to severe disease activity. Histologic Geboes Score is the most commonly used histological score in ulcerative colitis. Evaluation according to the histologic Geboes score is divided into 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\], and each grade of the score is divided in 4 subcategories. The Geboes score ranges from 0.0 to 5.4, with higher values indicating more severe inflammation.
Time frame: weeks 14, 24, 52, 100
Change in the Geboes score from the baseline.
Evaluation according to the histologic Geboes score is divided into 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\], and each grade of the score is divided in 4 subcategories. The Geboes score ranges from 0.0 to 5.4, with higher values indicating more severe inflammation.
Time frame: weeks 14, 24, 52, 100
Change in the partial Mayo score from the baseline
The assessment of the partial Mayo score ranges from 0 to 9 points, which are derived from 3 subscores, each of which is evaluated as 0 to 3 points: * Stool frequency assessment (0 to 3 points). * Evaluation of blood presence in the stool (0 to 3 points). * Physician's global assessment (0 to 3 points). A higher score indicates greater disease activity. It is a modification of the total Mayo score, from which Mayo Endoscopic Score (MES) was excluded.
Time frame: weeks 14, 24, 52, 100
Proportion of subjects who achieved a clinical response of ≥50% from baseline
Clinical response measured by two-component patient reported outcomes (PRO2) scale consist of the patient-derived items from the Mayo score (rectal bleeding and stool frequency). PRO2 scale ranges from 0-6 with higher values indicating worse outcome.
Time frame: weeks 14, 24, 52, 100
Change in the fecal calprotectin level from the baseline
Time frame: weeks 14, 24, 52, 100
Change in the highly sensitive C-reactive protein level from the baseline
Time frame: weeks 14, 24, 52, 100
Changes in the proportion of subjects with extra-intestinal manifestations from the baseline
Time frame: weeks 14, 24, 52, 100.
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Jan 2027, 17 months after the start.
Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's planned 17 months is below that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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