Study of BCD-261 Drug Effects Compared to Placebo in Adults Aged 18 to 75 with Moderate to Severe Active Crohns Disease

What this Trial Is About

Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the study drug BCD-261 in patients with moderate to severe active Crohns Disease. This study involves adult men and women aged 18 to 75 years who have had an inadequate response to previous treatments such as glucocorticoids, immunosuppressants, or biologics. The trial is designed to better understand the dose-response relationship of BCD-261 compared to a placebo in this patient group. Participants are randomly assigned to one of five groups receiving different dosing regimens of BCD-261 or placebo. Four groups receive varying doses of BCD-261 low, medium, high during induction weeks 0-12 and maintenance phases, with some groups transitioning between doses. The fifth group receives placebo until the primary endpoint assessment at week 14, after which they switch to the medium dose of BCD-261. During the study, participants will be closely monitored for clinical remission and endoscopic response at week 14, with additional remission assessments at week 24. The study includes comprehensive evaluations such as safety monitoring and pharmacokinetic and pharmacodynamic assessments. Participants will be involved throughout the induction and maintenance periods with scheduled visits and assessments to track treatment effects and safety over time.

Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease