Crohn's & Colitis

Study Objective:

The objectives of this study are to evaluate the efficacy and safety of oral Trichuris suis ova suspension (TSO), as compared to placebo, in patients with moderately to severely active Crohn’s disease. Coronado Biosciences is sponsoring this study.

Disease Information:

Crohn’s Disease

Moderate, Severe

Study Details:

Drug Comparison:

Crohn's disease, an autoimmune disease, is a chronic disorder of the bowel characterized by relapsing inflammatory process. Crohn’s disease affects between 400,000 and 600,000 people in North America.  There is no known pharmacological or surgical cure for CD; treatment options are limited to the control of symptoms, maintenance of remission, and prevention of relapse. 

While it is recognized that there is probably a genetic disposition in certain individuals for the development of autoimmune diseases, the rate of increase in incidence of autoimmune diseases cannot be explained by genetics alone. There is evidence that one of the primary reasons for the increase in autoimmune diseases in the industrialized nations is the significant change in environmental factors over the last century. Environmental factors include exposure to certain artificial chemicals from industrial processes, medicines, farming and food preparation. It is posited that the absence of exposure to certain parasites, bacteria and viruses is playing a significant role in the development of autoimmune diseases in the more sanitized Western industrialized nations.

Epidemiological studies show that like other autoimmune diseases, IBD is most common in Western industrialized countries that are characterized by affluent societies living in sanitized environments.  IBD is rare in developing countries with less clean environments and more crowded living conditions.  These epidemiologic findings suggest that the prevalence of IBD is inversely correlated to the prevalence of helminthic parasites in that population.

Helminths are parasitic worms such as hookworms and whipworms.  The history of helminths living in the intestinal tract or other locations of their host can be traced back to the earliest record of human beings, and colonization of humans with these organisms was nearly universal until the early 20th century.  Although effective preventive and therapeutic measures have been developed for most parasitic worms, helminth infections are still very common in the developing world today.  It has been estimated that more than one billion individuals worldwide are infected with one or more helminths, with the highest frequency found in children subjected to poor sanitation.

Helminthic therapy is the treatment of autoimmune diseases and immune disorders by means of deliberate infestation with a helminth or with the ova of a helminth.  Helminths may protect from or even treat intestinal inflammation. Administration of Trichuris suis ova has showed promising results in treating some forms of irritable bowel syndrome and may become an effective treatment option for patients with Crohn’s disease.

Aim

This current Phase II study is intended to assess the efficacy of oral CNDO 201 Trichuris suis ova suspension (TSO) in patients with Crohn’s disease.  This study will allow for assessment of the safety and tolerability of TSO over the course of a 12-week treatment period

Possible Risks and Side Effects:

Gastrointestinal disorders and other events have been reported, including diarrhea, upper abdominal pain, and flatulence.  As with any investigational drug, additional side effects may also be possible.

Explanation of Participation:

This is a randomized, double-blind, placebo-controlled, multicenter study with a parallel group design to evaluate the safety and efficacy oral CNDO-201 Trichuris suis ova 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.  The study will have 4 phases:

• Screening period, comprising up to 5 weeks prior to Baseline (Day 0).
• Double-blind treatment period (TSO or placebo) for 12 weeks
• Open-label treatment period with TSO for 12 weeks
• Post-Treatment Follow-Up phase, during which no TSO treatment will be given.  Patients will be evaluated for safety at 8 weeks and 26 weeks following the end of either the double-blind or the open-label treatment period.

Patients will be given doses of either TSO or placebo every other week for a total of 6 doses; during this double-blind period, the treatment you are given will not be known to you or to your doctor.  Following this 12 week period, ALL patients will then be treated with TSO for an additional 12 weeks; during this period, you will be receiving TSO every 2 weeks. 

A total of approximately 220 patients with moderately to severely active Crohn’s disease will be enrolled. Your participation in this study may last up to approximately 49 weeks:  (a) 1 month screening (1 - 5 wk), (b) 3 month Double-Blind (12 wk), (c) 3 month Open-Label (12 wk), (d) 6 month follow-up (20 wk)

Observation Period:

12-week treatment period

Participant Criteria:

Adult (18+)

Female, Male

Patient Criteria:

You may be eligible for the research study:

• You are 18 to 65 years old.
• You have an established diagnosis of Crohn’s disease for at least 3 months confirmed by endoscopic and histological, or endoscopic and radiological criteria. 
• You have active, symptomatic Crohn’s disease

You may not be eligible for this study if:

• You have known Crohn’s lesions in the upper GI-tract (esophagus, stomach, duodenum, jejunum) with present symptoms.
• You have ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
• You have had bowel surgery in past 6 months prior to Screening.
• You have had resection of more than 50 cm of the ileum. 
• You have current ileostomy or colostomy.

If you would like to receive more information regarding the Crohn’s research study, please contact the study contact listed above or visit www.clinicaltrials.gov.