Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Crohn's Disease (CD)
In brief
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 Crohn's Disease. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active Crohn's Disease and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics/targeted immunosuppressants.
Key facts
- Study ID
- NCT07078994
- Run by
- Biocad
- People needed
- 204
- Starts
- 2025-08-14
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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).
- 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 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.
- 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.
- 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.
- 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.
- 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).
You may not qualify if…
- 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.
- A history of primary sclerosing cholangitis.
- Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.
- Presence of an endoscopically obstructed stricture/stenosis of the intestine at the time of signing the ICF.
- A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).
- A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.
- 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.
- 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, 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:
- Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.
- Use of anti-integrins or IL-12/23 inhibitors within 12 weeks before signing the ICF or during the screening period.
- Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to 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.
- 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 signing the ICF or during screening.
Where it is running
- LLC Medical Center "ASTRA" — Barnaul, Altayskiy Kray, Russia (enrolling)
- Republican Clinical Hospital named after G.G. Kuvatov — Ufa, Bashkortostan Republic, Russia (enrolling)
- State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" — Moscow, Moscow, Russia (enrolling)
- Llc "Novosibirsk Gastrocenter" — Novosibirsk, Novosibirsk Oblast, Russia (enrolling)
- 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, Russia (enrolling)
- 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, Russia (enrolling)
- LLC "Research Center Eco-Safety" — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)
- State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of the Republic of Tatarstan" — Kazan', Tatarstan Republic, Russia (enrolling)
- "South Ural State Medical University" of the Ministry of Health of the Russian Federation — Chelyabinsk, Russia (enrolling)
- Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency — Krasnoyarsk, Russia (enrolling)
- Regional State Healthcare Institution "Regional Clinical Hospital — Krasnoyarsk, Russia (enrolling)
- Llc "Olla-Med" — Moscow, Russia (enrolling)
- Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department — Moscow, Russia (enrolling)
- State Healthcare Institution of the City of Moscow "V.M. Buyanov City Clinical Hospital of the Moscow City Healthcare Department" — Moscow, Russia (enrolling)
- Branch of the LLC "Hadassah Medical LTD" — Moscow, Russia (enrolling)
- 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, Russia (enrolling)
- Saint Petersburg State Healthcare Institution "City Hospital of the Holy Martyr Elizabeth" — Saint Petersburg, Russia (enrolling)
- 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, Russia (enrolling)
- State Healthcare Institution Ulyanovsk Regional Clinical Hospital — Ulyanovsk, Russia (enrolling)
- State Healthcare Institution "Primorsky Regional Clinical Hospital No. 1" — Vladivostok, Russia (enrolling)
Full record on ClinicalTrials.gov
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