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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038766
Recruitment Status : Terminated (Unable to enroll into study.)
First Posted : June 7, 2002
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: semapimod Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Study Start Date : June 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Semapimod 60 mg
Semapimod 60 mg IV x 5 days
Drug: semapimod
semapipmod 60 mg IV x 5 days
Other Name: CNI-1493

Experimental: Semapimod IV 30 mg
Semapimod IV 30 mg x 5 days
Drug: semapimod
IV 30 mg x 5 days
Other Name: CNI-1493

Placebo Comparator: Placebo
Placebo IV x 3 or 5 days
Drug: placebo
placebo IV

Primary Outcome Measures :
  1. Change in CDAI [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. Change in IBDQ [ Time Frame: Day 29 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038766

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United States, California
Institute of Healthcare Assessment
San Diego, California, United States, 92120
United States, Florida
University of Florida
Gainesville, Florida, United States
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Mount Sinai School of Medicine
New York, New York, United States
United States, North Carolina
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States, 28207
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Ferring Pharmaceuticals
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Principal Investigator: Daan Hommes, M Academic Medical Center, Netherlands
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Responsible Party: Ferring Pharmaceuticals Identifier: NCT00038766    
Other Study ID Numbers: CNI-1493 CD-02
First Posted: June 7, 2002    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012
Keywords provided by Ferring Pharmaceuticals:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors