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 Ulcerative Colitis (ULTRAMARINE)

NCT07080034 Phase 2 RECRUITING

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 ulcerative colitis. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active ulcerative colitis and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics/targeted immunosuppressants.

Details

Lead sponsor	Biocad
Phase	Phase 2
Status	RECRUITING
Enrolment	198
Start date	2025-08-14
Completion	2028-10

Conditions

• Ulcerative Colitis (UC)

Interventions

• anti-TL1A monoclonal antibody, low dose
• anti-TL1A monoclonal antibody, medium dose
• anti-TL1A monoclonal antibody, high dose
• Placebo

Primary outcomes

• Proportion of subjects who achieved clinical remission — week 14
  Proportion of subjects with modified Mayo score ≤2 points (endoscopic mucosal score ≤1, stool blood score = 0, stool frequency score ≤1, assessment for each component should not exceed the baseline level)

Countries

Russia