NCT07078994

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

A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Subjects meeting the eligibility criteria will be randomized in 5 groups to receive one of four studied dosage regimens of BCD-261 or placebo. The study groups will differ in drug dosages of BCD-261 (low, medium, high) during the induction and maintenance periods of therapy. After the primary endpoint assessment subjects in placebo group will be switched to BCD-261 medium studied dose.

Conditions

• Crohn's Disease (CD)

Interventions

Type	Name	Description
BIOLOGICAL	anti-TL1A monoclonal antibody, low dose	injection
BIOLOGICAL	anti-TL1A monoclonal antibody, medium dose	injection
BIOLOGICAL	anti-TL1A monoclonal antibody, high dose	injection
OTHER	Placebo	injection

Timeline

• Start date: 2025-08-14
• Primary completion: 2027-05-01
• Completion: 2029-01-01
• First posted: 2025-07-22
• Last updated: 2025-09-17

Locations

20 sites across 1 country: Russia