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New hope for Crohn's? experimental antibody BCD-261 enters Mid-Stage trial

NCT ID NCT07078994

Disease control Sponsor: Biocad Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a new drug called BCD-261 in 204 adults with moderate to severe active Crohn's disease who haven't improved with standard treatments. Participants receive either a low, medium, or high dose of BCD-261 or a placebo by injection. The goal is to see if the drug can reduce symptoms and heal the gut lining.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCD-261 (anti-TL1A monoclonal antibody)
What this could lead to
If successful, this could lead to a new treatment option for people with moderate to severe Crohn's disease who haven't responded well to other therapies.
What could go wrong
This is an early Phase 2 trial, so it's not yet proven to work. The drug may not be more effective than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease (CD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chelyabinsk, 454092, Russia

  • Branch of the LLC "Hadassah Medical LTD"

    RECRUITING

    Moscow, 121205, Russia

    Contact Email: •••••@•••••

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

    RECRUITING

    Krasnoyarsk, 60037, Russia

  • 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

    RECRUITING

    Saint Petersburg, 197022, Russia

  • 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

    RECRUITING

    Saint Petersburg, 191015, Russia

  • Federal State Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

    RECRUITING

    Rostov-on-Don, Rostov Oblast, 344022, Russia

  • Federal State Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

    RECRUITING

    Rostov-on-Don, Rostov Oblast, 344022, Russia

  • LLC "Research Center Eco-Safety"

    RECRUITING

    Saint Petersburg, Sankt-Peterburg, 196143, Russia

  • LLC Medical Center "ASTRA"

    RECRUITING

    Barnaul, Altayskiy Kray, 656049, Russia

    Contact Email: •••••@•••••

  • Llc "Novosibirsk Gastrocenter"

    RECRUITING

    Novosibirsk, Novosibirsk Oblast, 630007, Russia

    Contact Email: •••••@•••••

  • Llc "Olla-Med"

    RECRUITING

    Moscow, 105554, Russia

    Contact Email: •••••@•••••

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

    RECRUITING

    Moscow, 111123, Russia

    Contact Email: •••••@•••••

  • Regional State Healthcare Institution "Regional Clinical Hospital

    RECRUITING

    Krasnoyarsk, 660022, Russia

  • Republican Clinical Hospital named after G.G. Kuvatov

    RECRUITING

    Ufa, Bashkortostan Republic, 450005, Russia

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

    RECRUITING

    Saint Petersburg, 195257, Russia

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

    RECRUITING

    Kazan', Tatarstan Republic, 420064, Russia

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

    RECRUITING

    Vladivostok, 690091, Russia

  • State Healthcare Institution Ulyanovsk Regional Clinical Hospital

    RECRUITING

    Ulyanovsk, 432063, Russia

    Contact Email: •••••@•••••

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

    RECRUITING

    Moscow, 115516, Russia

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

    RECRUITING

    Moscow, Moscow, 129110, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.