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

NCT00295282 | Completed Phase 1

• 2 other identifiers: MDX1100-01IM129-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; UC; Colitis

Outcome Measures

Primary Outcomes (1)

• incidence and severity of treatment-emergent adverse events

  events will be followed to resolution

Secondary Outcomes (6)

• vital sign measurements

  study duration - each visit

• clinical laboratory tests

  study duration - each visit

• immunogenicity assessment

  dosing and follow up phases

• physical examinations

  study duration - each visit

• Electrocardiograph

  periodically through study duration

Study Arms (1)

1

EXPERIMENTAL

patients will receive active MDX-1100

Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody)

Interventions

MDX-1100 (anti-CXCL10 human monoclonal antibody) DRUG

Patients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

DMI Health Care Group, Inc.

Largo, Florida, 33773, United States

Location

Metropolitan Gastroenterology Group, PC

Chevy Chase, Maryland, 20815, United States

Location

University of Medicine and Dentistry of New Jersery (UMDNJ)

New Brunswick, New Jersey, 08903, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis

Interventions

MDX-1100

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 23, 2010

Record last verified: 2010-04

Locations

US (5)