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

NCT07078994 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Crohn's Disease (CD)

Interventions

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina V Zinkina-Orikhan · Director of Clinical Development Department, BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2027-05-31
Completion
2029-01-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078994 on ClinicalTrials.gov