CNI-1493 for Treatment of Moderate to Severe Crohn's Disease (CD02)

August 22, 2012 updated by: Ferring Pharmaceuticals

A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn's Disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Crohn's disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn's disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.

Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.

CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.

The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn's Disease in a placebo controlled setting.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Institute of Healthcare Assessment
    • Florida
      • Gainesville, Florida, United States
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • University of Chicago
    • Missouri
      • St. Louis, Missouri, United States
        • Washington University School of Medicine
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • New York, New York, United States
        • Mount Sinai School of Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology, PLLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Oklahoma Foundation for Digestive Research
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive
  • Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy
  • Patients receiving medications for CD must be on stable doses entering the study
  • Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening

Exclusion Criteria

  • Patients with any ostomy or extensive bowel resection
  • Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery
  • Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin
  • Treatment with any other experimental therapeutics within the last 4 weeks before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semapimod 60 mg
Semapimod 60 mg IV x 5 days
Drug: semapimod
semapipmod 60 mg IV x 5 days
Other Names:
  • CNI-1493
Drug: semapimod
IV 30 mg x 5 days
Other Names:
  • CNI-1493
Experimental: Semapimod IV 30 mg
Semapimod IV 30 mg x 5 days
Drug: semapimod
semapipmod 60 mg IV x 5 days
Other Names:
  • CNI-1493
Drug: semapimod
IV 30 mg x 5 days
Other Names:
  • CNI-1493
Placebo Comparator: Placebo
Placebo IV x 3 or 5 days
Drug: placebo
placebo IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in CDAI
Time Frame: Day 29
Day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in IBDQ
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Daan Hommes, M, Academic Medical Center, Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

June 5, 2002

First Submitted That Met QC Criteria

June 6, 2002

First Posted (Estimate)

June 7, 2002

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNI-1493 CD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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