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

Study acronym: ULTRAMARINE
StatusRecruiting
PhasePhase 2
SponsorBiocad
Started2025-08-14
View on ClinicalTrials.gov ↗

Amendment history

2025-09-16
Study Identification, Study Status, Arms and Interventions, Outcome Measures v1
Start dateestimated 2025-07→confirmed 2025-08-14
Study title-46 characters
A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodyn [...]
2025-07-15
Original filing
Biocad
26 trials monitored
See all monitored trials
Ulcerative Colitis
582 trials monitored
See 29 trials at risk
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.
Trial Details
NCT Number NCT07080034
Lead Sponsor Biocad
Conditions Ulcerative Colitis (UC)
Enrollment 198 participants
Start Date 2025-08-14
Primary Completion 2027-01 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2025-09-19