drugset / Trial / NCT03800420

Efficacy and Safety of BBT-401-1S in Ulcerative Colitis

NCT03800420 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis. This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.

Timeline

Start
2019-04-22
Primary completion
2020-05-18
Completion
2020-07-31

Outcome

Outcome not reported

Stopped: “to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject BBT-401-1S Peptide — Oral

Indications