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

Coronado Biosciences, Inc.72 sites in 1 country250 target enrollmentJuly 2012

ConditionsCrohn's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Coronado Biosciences, Inc.
Enrollment: 250
Locations: 72
Primary Endpoint: Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

October 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Coronado Biosciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is male or female, 18 to 65 years old.
•Patient with established diagnosis of Crohn's disease (CD) for at least 3 months confirmed by endoscopic and histological, or endoscopic and radiological criteria.
•Patient with localization of CD either in terminal ileum (L1), in colon (L2) or ileocolitis (L3), all without upper gastrointestinal involvement (- L4) according to the Montreal classification (2005).
•Patient with active, symptomatic CD manifested by CDAI ≥ 220 and ≤ 450 at Baseline.
•Patient with active intestinal inflammation as visualized by endoscopy within 8 weeks prior to Baseline.
•Patient is not using concomitant medication for treatment of underlying Crohn's disease with the following exceptions: concomitant medications may include: 1) Oral or rectal sulfasalazine, mesalazine (5-ASA), or mesalazine derivative, if receiving it for \>6 weeks and if receiving the same dose for at least 4 weeks; 2) Oral prednisone up to 15 mg/day, or budesonide if receiving it for \>4 weeks and if receiving the same dose for at least 4 weeks; and 3) Azathioprine (up to 2.5 mg/kg daily) or 6-mercaptopurine (up to 2 mg/kg daily) if receiving it for \>3 months and if receiving the same dose for at least 8 weeks prior to Baseline.
•Hemoglobin of at least 10 g/dl, normal white blood cell and platelet count \> lower limit of normal at screening.
•For females of childbearing potential, negative serum pregnancy test prior to enrollment, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration \[including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants, and total abstinence\]. Pregnancy tests are not required (indicate "N/A") for males or females not of childbearing potential (post-menopausal with last menstrual period \>1 year ago or total hysterectomy).
•Patient has the ability to provide informed consent.

Exclusion Criteria

•Patient with known Crohn's lesions in the upper GI-tract (esophagus, stomach, duodenum, jejunum) with present symptoms.
•Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
•Bowel surgery in past 6 months prior to Screening.
•Resection of more than 50 cm of the ileum.
•Current ileostomy or colostomy.
•Ongoing or active septic complications, is hospitalized or exhibiting signs of toxicity (sepsis), has symptomatic strictures, or impending obstruction or anticipating a need for blood transfusion for gastrointestinal bleeding or in whom surgical intervention may be imminent.
•Patient with gastrointestinal abscess or perforation.
•Patient with fistulae having a new onset within 2 months of Screening with moderate to severe local inflammation.
•Patient with history of colorectal cancer or colorectal dysplasia. Patients with completely resected sporadic adenomas may be enrolled.
•Patient requiring parenteral or tube feeding.