This study will examine the safety and effectiveness of an experimental drug called J695 for
treating patients with Crohn's disease-a long-term recurring inflammation of the small and
large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine),
5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against
TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many
patients do not respond adequately to treatment or they develop severe side effects from the
medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical
to a human antibody but chemically changed so that it can attach to and eliminate an
inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have
shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can
also heal inflammation that has already developed.
Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be
eligible for this study. Candidates will be screened with a medical history and physical
examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and
possibly a review of medical records. They will complete a Crohn's Disease Activity Index
Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment
groups, as follows:
Group 1
Patients in this group will receive an injection of either J695 or placebo (a solution that
does not contain any active medicine) under the skin on day 1 of the study, on day 29, and
then weekly for a total of seven injections. After the last injection, patients will be
followed for an additional 18 weeks. They will be monitored periodically throughout the study
with physical examinations, disease activity index scores, and blood and urine tests.
Group 2
Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and
then weekly for a total of six injections. They will be followed for an additional 18 weeks.
Patients will be monitored as described above for group 1.
Participants may be asked to undergo additional tests as part of a sub-study in this
protocol. These include colonoscopies to examine changes in inflammation in the gut and blood
tests to analyze changes in the cells and body chemicals that affect the inflammation.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)