Study of BCD-261 Drug for Moderate to Severe Active Ulcerative Colitis in Adults Aged 18 to 75 Evaluating Safety, Effectiveness, and Immune Response Compared to Placebo

What this Trial Is About

Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-261, a study drug, in adults aged 18 to 75 years with moderate to severe active ulcerative colitis who have not responded adequately to previous treatments such as glucocorticoids, immunosuppressants, or biologics. This Phase 2 randomized, double-blind, placebo-controlled study aims to understand the dose-response relationship of BCD-261 in this patient population. Participants will be randomly assigned to one of five groups to receive different doses of BCD-261 or placebo. Four groups receive varied doses of BCD-261low, medium, or highduring an induction period once every 4 weeks until Week 12 followed by a maintenance period once every 8 weeks from Week 20 to Week 100 with adjusted doses. The placebo group receives injections at Weeks 0, 4, 8, and 12, then switches to BCD-261 medium dose injections every 4 weeks until Week 28, followed by a low dose every 8 weeks until Week 100. During the study, participants will be monitored regularly with assessments at specific weeks, including evaluating clinical remission at Week 14 as the primary outcome. Additional measurements at Week 24 and ongoing safety monitoring will be performed. The study involves injections, regular follow-up visits, and evaluations of disease activity, safety, and drug effects over nearly two years to gather comprehensive data on BCD-261s impact in ulcerative colitis.

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