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

This study has been terminated.
(Unable to enroll into study.)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00038766
First received: June 5, 2002
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Crohn Disease
Drug: semapimod
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change in CDAI [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in IBDQ [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semapimod 60 mg
Semapimod 60 mg IV x 5 days
Drug: semapimod
semapipmod 60 mg IV x 5 days
Other Names:
  • Semapimod
  • CNI-1493
Experimental: Semapimod IV 30 mg
Semapimod IV 30 mg x 5 days
Drug: semapimod
IV 30 mg x 5 days
Other Names:
  • semapimod
  • CNI-1493
Placebo Comparator: Placebo
Placebo IV x 3 or 5 days
Drug: placebo
placebo IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038766

Locations
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
Investigators
Principal Investigator: Daan Hommes, M Academic Medical Center, Netherlands
  More Information

Publications:
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00038766     History of Changes
Other Study ID Numbers: CNI-1493 CD-02
Study First Received: June 5, 2002
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Semapimod
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014