Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo
NCT ID: NCT00739986
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2002-10-31
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Semapimod 60 mg IV x 1 day, placebo IV x 2 days
Semapimod
semapimod 60 mg IV x 1 day, placebo x 2 days
2
Semapimod 60 mg IV x 3 days
Semapimod
Semapimod 60 mg IV x 3 days
3
Placebo comparator IV x 3 days
Placebo
placebo IV x 3 days
Interventions
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Semapimod
semapimod 60 mg IV x 1 day, placebo x 2 days
Semapimod
Semapimod 60 mg IV x 3 days
Placebo
placebo IV x 3 days
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Daan Hommes, MD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center, Netherlands
Locations
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Institute of Healthcare Assessment
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Advanced Gastroenterology Associates
Suwanee, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Asher Kornbluth, MD
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Gastroenterology Associates
Bristol, Tennessee, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Academic Hospital Gasthuisberg
Leuven, , Belgium
Benjamin Franklin University
Berlin, , Germany
Medizinischen Hochschule-Hannover
Hanover, , Germany
Universitats Klinikum Heidelberg
Heidelberg, , Germany
University of Kiel
Kiel, , Germany
Gastroenterologische Fachpraxis
Minden, , Germany
Stadtisches Krankenhaus Munchen-Bogenhausen
München, , Germany
University of Munster
Münster, , 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 Litwinsky, , Israel
Academic Medical Center
Amsterdam, , Netherlands
Free University (Vrije Universiteit)
Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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Other Identifiers
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CNI-1493-CD04
Identifier Type: -
Identifier Source: org_study_id
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