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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00739986
First received: August 20, 2008
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Crohn's 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 1 or 3 Days' Treatment vs. Placebo

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Crohn's Disease Activity Index (CDAI) score [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Crohn's disease endoscopic index of severity (CDEIS) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Change in level of C-reactive protein (CRP) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Safety (Adverse events) [ Time Frame: Days 29 and 57 ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: October 2002
Study Completion Date: August 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00739986

Locations
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
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Academic Hospital Gasthuisberg
Leuven, Belgium
Germany
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
Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Hospital
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel
Netherlands
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
Investigators
Principal Investigator: Daan Hommes, MD Academic Medical Center, Netherlands
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739986     History of Changes
Other Study ID Numbers: CNI-1493-CD04
Study First Received: August 20, 2008
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medical Ethics Review Committee (METC)
Israel: Ministry of Health
Belgium: Institutional Review Board

Keywords provided by Ferring Pharmaceuticals:
Crohn's Disease
TNF-alpha
IL-6
MAP Kinase
CNI-1493

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
CNI 1493
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014