Trial Information

Summary: Single Dose, Placebo Controlled Study of MDX-1100 in Patients With Active Ulcerative Colitis

This is a blinded placebo-controlled study of MDX-1100. Patients with ulcerative colitis may receive one dose of MDX-1100 or placebo at 0.3, 1.0, 3.0 or 10mg/kg. Eight patients will be enrolled at each dose level, starting at the lowest dose level, for a total of 32 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of a single dose of MDX-1100 in patients with ulcerative colitis. Other study objectives include a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100

Patient Inclusion Criteria

• signed informed consent and HIPAA
• must be 18 years or older
• patients with active ulcerative colitis with a DAI greater than or equal to 4 and less than or equal to 9.
• certain medications initiated at specific schedules prior to study drug administration may be enrolled.
• must meet screening laboratory values
• women of childbearing potential must be using effective contraception for at least 1 month prior to study entry and agree to continue contraception for the duration of their participation in the study, and
• Sexually active male patients must use a barrier method of contraception during the course of the study.

Patient Exclusion Criteria

• History of colectomy, partial colectomy, current ostomy, or pouchitis
• Presence of Cushing's Syndrome
• Toxic megacolon or fulminant disease likely to require colectomy
• Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins 8 weeks or less prior to treatment with MDX-1100
• Any experimental treatment 4 weeks or less prior to treatment with MDX-1100
• Primary or secondary immunodeficiency
• Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ
• Active major psychiatric disease(stable depression receiving appropriate medical management will be permitted)
• Evidence of acute or chronic infection or neoplasm on Screening chest radiography
• Current treatment for TB or positive PPD without prophylaxis
• Herpes zoster 3 months or less prior to screening
• Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months, or congestive heart failure
• Active infectious disease requiring i.v. antibiotics within the past 4 weeks or oral antibiotics at the time of enrollment
• Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities
• History of cerebrovascular disease requiring medication/treatment
• Anticoagulation therapy or a known bleeding disorder
• Seizure disorder requiring active therapy
• Known drug or alcohol abuse
• Positive tests for HIV, HBV, or HCV
• Pregnant or nursing
• Any underlying medical condition that in the Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events, or
• Inability or unwillingness to return for Follow-up visits

For more information, please visit this site.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 1, 2008 at 5:45:47 AM