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.
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.
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.
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.
Parallel
anti-TL1A monoclonal antibody, low dose
Biological/Vaccineinjection
anti-TL1A monoclonal antibody, medium dose
Biological/Vaccineinjection
anti-TL1A monoclonal antibody, high dose
Biological/Vaccineinjection
Placebo
Other interventioninjection
Proportion of subjects who achieved clinical remission
Proportion of subjects with Crohn's Disease Activity Index (CDAI) score of \<150
Proportion of subjects who achieved an endoscopic response
Proportion of subjects with ≥50% reduction Simple Endoscopic Score for Crohn's Disease (SES-CD) from the baseline
Proportion of subjects who achieved clinical remission
Proportion of subjects with Crohn's Disease Activity Index (CDAI) score of \<150
Proportion of subjects who achieved a clinical response
Proportion of subjects with Crohn's Disease Activity Index (CDAI) score reduction ≥100-point from baseline
Proportion of subjects who achieved clinical remission
Proportion of subjects with Crohn's Disease Activity Index (CDAI) of \<150
Proportion of subjects who achieved clinical remission
Proportion of subjects with Crohn's Disease Activity Index (CDAI) score of \<150 points among subjects who had achieved a clinical response, defined as a ≥100-point reduction from baseline in the CDAI score at Week 14
Proportion of subjects who achieved clinical remission
Proportion of subjects with Crohn's Disease Activity Index (CDAI) score of \<150 points without the use of glucocorticoids (for at least 12 weeks) among subjects who were initially receiving glucocorticoid therapy
