NCT01576471

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

A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Coronado Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Trichuris suis ova (TSO)	TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
BIOLOGICAL	Placebo	Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2012-04-12
• Last updated: 2017-06-29
• Results posted: 2017-06-29

Locations

73 sites across 1 country: United States