CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Trichuris suis ova +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Confirmed Crohn's disease diagnosis with minimum 3 months disease duration
  • ✓Age 18–55 years
  • ✓Stable concomitant medications (5-ASA/sulfasalazine >6 weeks, prednisone ≤15 mg/day >4 weeks, azathioprine/6-mercaptopurine >3 months) maintained throughout observation period
  • ✓Hemoglobin ≥12 g/dL at screening
Key exclusion· 15
  • ✕Ulcerative colitis, indeterminate colitis, or ulcerative proctitis
  • ✕Bowel surgery within 6 months or resection of >50 cm of ileum
  • ✕Ileostomy or colostomy
  • ✕Hospitalization, sepsis, significant strictures, impending obstruction, or risk of imminent surgery/transfusion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01434693
NCT01434693Phase 1Completed
CompareCT.gov

A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease

Coronado Biosciences, Inc.·interventional·Posted Sep 15, 2011·Updated May 20, 2013

In Brief

A Phase 1 clinical trial evaluating Trichuris suis ova and Placebo for Crohn's Disease. Completed, enrolled 36 participants across 7 sites.

Detailed Summary

This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2011
Enrollment StartNov 1, 2011
Primary CompletionApr 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.8 years ago

Interventions

Trichuris suis ovabiological

single dose

Placeboother