CNI-1493 for Treatment of Moderate to Severe Crohn's Disease (CD02)

Ferring

Status and phase: Terminated; Phase 2

Conditions: Crohn Disease

Treatments: Drug: placebo; Drug: semapimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038766

CNI-1493 CD-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups, including a placebo group

Semapimod 60 mg

Experimental group

Description:

Semapimod 60 mg IV x 5 days

Treatment:

Drug: semapimod

Drug: semapimod

Semapimod IV 30 mg

Experimental group

Description:

Semapimod IV 30 mg x 5 days

Treatment:

Drug: semapimod

Drug: semapimod

Placebo

Placebo Comparator group

Description:

Placebo IV x 3 or 5 days

Treatment:

Drug: placebo