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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

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 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.

Key facts

Study ID

NCT07080034

Run by

Biocad

People needed

198

Starts

2025-08-14

Expected to finish

2028-10-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• 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.
• 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).

You may not qualify if…

• 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.
• 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 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)
• 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)
• 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)
• State Institution of Healthcare of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" — Moscow, Russia (enrolling)
• Llc "Novosibirsk Gastrocenter" — Novosibirsk, 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)
• LLC "Research Center Eco-Safety" — 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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