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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

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

Amendment history

2025-09-16
minor
Study Status v2
Start dateestimated 2025-07→confirmed 2025-08-14
2025-07-22
minor
Study Identification, Study Status v1
Study title-37 characters
A Randomized Double-Blind, Placebo-ControlledClinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacody [...]
2025-07-14
minor
Original filing
26 trials monitored
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608 trials monitored
See 27 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 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.
Trial Details
NCT Number NCT07078994
Lead Sponsor Biocad
Conditions Crohn's Disease (CD)
Enrollment 204 participants
Start Date 2025-08-14
Primary Completion 2027-05 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-17