drugset / Trial / NCT01576471

Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo

NCT01576471 ↗

Phase 2 Completed 250 enrolled Coronado Biosciences, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active Crohn's disease. This study will also have an optional open-label extension for patients completing the double-blind phase of the study.

Timeline

Start
2012-07
Primary completion
2013-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Trichuris suis ova Other / unclassified 7500 unknown Oral

Indications