At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Trichuris suis ova (TSO) and Placebo for Crohn's Disease. Completed, enrolled 250 participants across 73 sites.
Detailed 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.
Study Details
Timeline
Interventions
TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)