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Ulcerative Colitis (UC)Phase 2ULTRAMARINENCT07080034

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

A Phase 2 study testing anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose and anti-TL1A monoclonal antibody, high dose in people with Ulcerative Colitis (UC), run by Biocad at 20 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose and anti-TL1A monoclonal antibody, high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
20 sitesRussia
Study dates
14 Aug 2025to Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
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  • 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.
  • 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).

Who cannot join

  • 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.
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  • 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 Janus kinase inhibitors within 2 weeks prior to signing the ICF or during the screening period.
  • Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
  • Using modulators of sphingosine-1-phosphate receptors within 10 weeks prior to signing the ICF or during the screening period.
  • Use of anti-integrins, IL-12/23 inhibitors within 12 weeks before 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.
  • Rectal administration of 5-ASCs within 2 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.
  • 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.
  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna V Gaponova contact

+7 (812) 380 49 33

gaponova@biocad.ru

Aleksey V Manziuk contact

+7 (812) 380 49 33

manziuk@biocad.ru

20 sites in 1 country

Russia20 sites, 20 recruiting

  • LLC Medical Center "ASTRA"

    Barnaul, Altayskiy Kray, 656049

    Principal Investigator, +7 (3852) 59 10 49, info@astra-barnaul.ru

    Recruiting

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

    Chelyabinsk, 454092

    +7 (351) 240 20 20, klinika_chgma@mail.ru

    Recruiting

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

    Kazan', Tatarstan Republic, 420064

    Principal Investigator, +7 (843) 231 20 02, mz.rkb@tatar.ru

    Recruiting

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

    Krasnoyarsk, 660022

    Principal Investigator, +7 (391) 274 31 50, skc@skc-fmba.ru

    Recruiting

  • Regional State Healthcare Institution "Regional Clinical Hospital"

    Krasnoyarsk, 660022

    Principal Investigator, +7 (391) 202 68 50, kkb@medgorod.ru

    Recruiting

  • Llc "Olla-Med"

    Moscow, 105554

    Principal Investigator, +7 495 105 99 05, info@olla-med.ru

    Recruiting

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

    Moscow, 111123

    Principal Investigator, +7 (495) 304 30 39, info@mknc.ru

    Recruiting

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

    Moscow, 115516

    Principal Investigator, +7 (495) 136 22 68, gkb12@zdrav.mos.ru

    Recruiting

  • Branch of the LLC "Hadassah Medical LTD"

    Moscow, 121205

    Principal Investigator, 7 495 186 41 48, info@hadassah.moscow

    Recruiting

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

    Moscow, 129110

    Principal Investigator, +7 499 674 07 09, mz_moniki_info@mosreg.ru

    Recruiting

  • Llc "Novosibirsk Gastrocenter"

    Novosibirsk, 630007

    Principal Investigator, +7 (383) 373 03 12, info@gastrocentr.ru

    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

    Principal Investigator, +7 (863) 285 32 13, klinika@rostgmu.ru

    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

    Principal Investigator, +7 863 201 44 50, gastro@rostgmu.ru

    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

    Principal Investigator, +7 812 303 50 00, rectorat@szgmu.ru

    Recruiting

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

    Saint Petersburg, 195257

    +7 (812) 555 05 55, biocad@biocad.ru

    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

    Principal Investigator, +7 812 429 03 31, klinika@spb-gmu.ru

    Recruiting

  • LLC "Research Center Eco-Safety"

    Saint Petersburg

    Principal Investigator, +7 (812) 500 52 03, nic@ecosafety.ru

    Recruiting

  • Republican Clinical Hospital named after G.G. Kuvatov

    Ufa, Bashkortostan Republic, 450005

    Principal Investigator, +7 (347) 246 33 30, ufa.rkbkuv@doctorrb.ru

    Recruiting

  • State Healthcare Institution Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

    Principal Investigator, +7 8422 73 62 63, info@uokb.ru

    Recruiting

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

    Vladivostok, 690091

    Principal Investigator, +7 (423) 240 06 24, prim_kkb1@mail.ru

    Recruiting

Other trials in Russia

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose, Placebo
Keywords
biologics, ulcerative colitis, monoclonal antibodies, TL1A
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-TL1A monoclonal antibody, low doseBiological

    injection

  • anti-TL1A monoclonal antibody, medium doseBiological

    injection

  • anti-TL1A monoclonal antibody, high doseBiological

    injection

  • PlaceboOther

    injection

Study groups in NCT07080034
Study groupRoleWhat they receive
BCD-261, medium dose induction/ low dose maintenance regimensExperimentalGroup 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.
Receives: Biological: anti-TL1A monoclonal antibody, low dose; Biological: anti-TL1A monoclonal antibody, medium dose
BCD-261, medium dose induction/ medium dose maintenance regimensExperimentalGroup 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.
Receives: Biological: anti-TL1A monoclonal antibody, medium dose
BCD-261, high dose induction/ medium dose maintenance regimensExperimentalGroup 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.
Receives: Biological: anti-TL1A monoclonal antibody, medium dose; Biological: anti-TL1A monoclonal antibody, high dose
BCD-261, high dose induction/ high dose maintenance regimensExperimentalGroup 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.
Receives: Biological: anti-TL1A monoclonal antibody, high dose
PlaceboPlacebo comparatorGroup 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: week 14

Secondary outcomes (1)

  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)

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start14 Aug 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080034
Sponsor's protocol ID
BCD-261-4
Acronym
ULTRAMARINE
Status last verified
Sep 2025
First submitted
15 Jul 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose and anti-TL1A monoclonal antibody, high dose in people with Ulcerative Colitis (UC), run by Biocad at 20 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna V Gaponova (+7 (812) 380 49 33, gaponova@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who achieved clinical remission (time frame: week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07080034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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