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

NCT01576471 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-06-29

Study results available
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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

Interventions

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)

Sponsors & Collaborators

  • Coronado Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Nova Silver · Coronado Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576471 on ClinicalTrials.gov