drugset
drugset / Trial / NCT04596293

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

NCT04596293 ↗

Phase 2 Completed 38 enrolled Bridge Biotherapeutics, Inc. Covance · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

Timeline

Start
2021-06-11
Primary completion
2022-05-17
Completion
2022-07-12

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs BBT-401-1S (800mg); p = 1.0000; Fisher Exact NCT04596293 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BBT-401-1S Peptide 800 mg Oral
Subject BBT-401-1S Peptide 1600 mg Oral

Indications

ulcerative colitis