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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• 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.

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