Status:
COMPLETED
Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Men and women at least 18 years of age.
- Baseline Crohn's Disease Activity Index (CDAI) 250-400.
- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
- 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.
- 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
- 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.
- 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)
- Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
- Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Exclusion
- Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
- History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
- 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.
- 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.
- Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
- Patients with known severe fixed symptomatic stenosis of the small or large intestine.
- Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
- Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
- Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- Patients with previous diagnosis of, or known, malignancies.
- Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
- 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.
- Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
- Women who were pregnant or breast-feeding.
- A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
- Patients who had received CNI-1493 in the past.
- More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00739986
Start Date
October 1 2002
End Date
August 1 2004
Last Update
November 9 2023
Active Locations (28)
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1
Institute of Healthcare Assessment
San Diego, California, United States, 92120
2
University of California, San Francisco
San Francisco, California, United States, 94115
3
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
4
Advanced Gastroenterology Associates
Suwanee, Georgia, United States, 30024