Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo (CD04)

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: NCT00739986
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Semapimod Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 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 1 or 3 Days' Treatment vs. Placebo
Study Start Date : October 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Semapimod 60 mg IV x 1 day, placebo IV x 2 days
Drug: Semapimod
semapimod 60 mg IV x 1 day, placebo x 2 days
Experimental: 2
Semapimod 60 mg IV x 3 days
Drug: Semapimod
Semapimod 60 mg IV x 3 days
Placebo Comparator: 3
Placebo comparator IV x 3 days
Drug: Placebo
placebo IV x 3 days

Primary Outcome Measures :
  1. Crohn's Disease Activity Index (CDAI) score [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Day 29 ]
  2. Crohn's disease endoscopic index of severity (CDEIS) [ Time Frame: Day 29 ]
  3. Change in level of C-reactive protein (CRP) [ Time Frame: Day 29 ]
  4. Safety (Adverse events) [ Time Frame: Days 29 and 57 ]

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

Inclusion Criteria:

  1. Men and women at least 18 years of age.
  2. Baseline Crohn's Disease Activity Index (CDAI) 250-400.
  3. Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
  4. Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
  5. Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:

    • those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving more than 25 mg/wk
    • those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
    • those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone or equivalent
    • those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
    • those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
  6. Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
  7. The screening laboratory tests were to meet the following criteria:

    Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)

  8. Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
  9. Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.

Exclusion Criteria:

  1. Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
  2. History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
  3. Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
  4. Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
  5. Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
  6. Patients with known severe fixed symptomatic stenosis of the small or large intestine.
  7. Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
  8. Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
  9. Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
  10. Patients with previous diagnosis of, or known, malignancies.
  11. Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
  12. History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
  13. Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
  14. Women who were pregnant or breast-feeding.
  15. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
  16. Patients who had received CNI-1493 in the past.
  17. More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication

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): NCT00739986

United States, California
Institute of Healthcare Assessment
San Diego, California, United States, 92120
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
Advanced Gastroenterology Associates
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Asher Kornbluth, MD
New York, New York, United States, 10128
Rochester General Hospital
Rochester, New York, United States, 14621
United States, Tennessee
Gastroenterology Associates
Bristol, Tennessee, United States, 37620
Gastroenterology Associates
Kingsport, Tennessee, United States, 37660
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Academic Hospital Gasthuisberg
Leuven, Belgium
Benjamin Franklin University
Berlin, Germany
Medizinischen Hochschule-Hannover
Hannover, Germany
Universitats Klinikum Heidelberg
Heidelberg, Germany
University of Kiel
Kiel, Germany
Gastroenterologische Fachpraxis
Minden, Germany
University of Munster
Muenster, Germany
Stadtisches Krankenhaus Munchen-Bogenhausen
Munchen, Germany
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Shaare Zedek Hospital
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel
Academic Medical Center
Amsterdam, Netherlands
Free University (Vrije Universiteit)
Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Principal Investigator: Daan Hommes, MD Academic Medical Center, Netherlands

Responsible Party: Ferring Pharmaceuticals Identifier: NCT00739986     History of Changes
Other Study ID Numbers: CNI-1493-CD04
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Ferring Pharmaceuticals:
Crohn's Disease
MAP Kinase

Additional relevant MeSH terms:
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