Crohn Disease
Conditions
Keywords
Inflammatory Bowel 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.
Interventions
DRUGsemapimod
semapipmod 60 mg IV x 5 days
DRUGplacebo
placebo IV
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CDAI | Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| Change in IBDQ | Day 29 |
Countries
United States
Outcome results
None listed