Crohn's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 (J695) in Patients With Active Crohn's Disease
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.
The purpose of this study is to evaluate the safety of and the clinical response to a human
monoclonal anti-interleukin-12 antibody (J695) administered to patients with Crohn's
disease. Crohn's disease, an incurable, chronic, relapsing inflammation of the small and
large intestine, affects approximately 500,000 people in the United States. The disease is
characterized by full-thickness involvement of the gut wall leading to episodes of abdominal
pain, diarrhea, hematochezia, weight loss and complications such as bowel obstruction,
fistula formation and extraintestinal manifestations. The rationale for this study is based
on two compelling observations. First, despite the standard therapeutic use of steroids,
aminosalicylates, antibiotics, antimetabolite immunosuppressants (6-MP, methotrexate), and
early agents of the emerging biologics class of drugs (anti-TNF alpha antibodies, e.g.), the
treatment of Crohn's disease is still troubled by loss of effectiveness of standard therapy
over time, outright nonresponsiveness, and serious medication side effects. For these
reasons newer agents for the treatment of Crohn's disease need to be developed and tested.
Second, studies in both animals and humans support a central role for IL-12 in the gut
inflammatory response in Crohn's disease. Administration of anti-IL-12 antibodies in animal
models has prevented inducible or ameliorated established colitis. For these reasons IL-12
is an appropriate therapeutic target for the treatment of Crohn's disease.
This study proposes to measure the toxicity and clinical effect of two doses of anti-IL-12
(J695) administered subcutaneously to patients with moderately active Crohn's disease. The
primary outcome measure is the rate and severity of adverse events. Secondary outcome
measures include J695 pharmacodynamics, incidence of anti-J695 antibodies, and clinical
response. A separate substudy at the NIH will measure gut lymphocyte apoptosis and gut and
peripheral blood cytokine responses to study drug as well as endoscopic and histologic
response to treatment. Our short-term goal is to assure good tolerance of anti-IL-12
treatment regimens in Crohn's disease patients and observe a beneficial clinical response.
The long-term goal of this study is to establish anti-IL-12 as an effective alternative with
a low risk profile in the therapeutic armamentarium for Crohn's disease.
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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