A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis

Completed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100.

Key facts

Study ID: NCT00295282
Run by: Bristol-Myers Squibb
People needed: 24
Starts: 2006-01-01
Expected to finish: 2008-01-01
Last updated by the study team: 2010-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

signed informed consent and HIPAA
must be 18 years or older
patients with active ulcerative colitis with a UCDAI 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.

You may not qualify if…

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

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
DMI Health Care Group, Inc. — Largo, Florida, United States
Metropolitan Gastroenterology Group, PC — Chevy Chase, Maryland, United States
University of Medicine and Dentistry of New Jersery (UMDNJ) — New Brunswick, New Jersey, United States
Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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