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

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ClinicalTrials.gov Identifier: NCT00038766
Recruitment Status : Terminated (Unable to enroll into study.)
First Posted : June 7, 2002
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 5, 2002
First Posted Date  ICMJE June 7, 2002
Last Update Posted Date August 23, 2012
Study Start Date  ICMJE June 2002
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
Change in CDAI [ Time Frame: Day 29 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
Change in IBDQ [ Time Frame: Day 29 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Official Title  ICMJE A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Drug: semapimod
    semapipmod 60 mg IV x 5 days
    Other Name: CNI-1493
  • Drug: semapimod
    IV 30 mg x 5 days
    Other Name: CNI-1493
  • Drug: placebo
    placebo IV
Study Arms  ICMJE
  • Experimental: Semapimod 60 mg
    Semapimod 60 mg IV x 5 days
    Intervention: Drug: semapimod
  • Experimental: Semapimod IV 30 mg
    Semapimod IV 30 mg x 5 days
    Intervention: Drug: semapimod
  • Placebo Comparator: Placebo
    Placebo IV x 3 or 5 days
    Intervention: Drug: placebo
Publications * Hommes D, van den Blink B, Plasse T, Bartelsman J, Xu C, Macpherson B, Tytgat G, Peppelenbosch M, Van Deventer S. Inhibition of stress-activated MAP kinases induces clinical improvement in moderate to severe Crohn's disease. Gastroenterology. 2002 Jan;122(1):7-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 3, 2009)
33
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
180
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038766
Other Study ID Numbers  ICMJE CNI-1493 CD-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daan Hommes, M Academic Medical Center, Netherlands
PRS Account Ferring Pharmaceuticals
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP