A Study of MDX-1100 in Subjects With Active Ulcerative Colitis (MDX1100-06)

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
      • Vancouver, British Columbia, Canada, V5Z 1H2
    • Ontario
      • Toronto, Ontario, Canada, M3N 2V7
  • Czech Republic
      • Olomouc, Czech Republic
      • Prague, Czech Republic
      • Strakonice, Czech Republic
      • Tabor, Czech Republic
      • Usti nad Labem, Czech Republic
      • Valasske Mezifici, Czech Republic
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Gyula, Hungary
      • Kaposvar, Hungary
      • Kecskemet, Hungary
      • Nagykanizsa, Hungary
      • Siofok, Hungary
      • Vac, Hungary
      • Zalaegerszeg, Hungary
  • Latvia
      • Daugavpils, Latvia
      • Riga, Latvia
      • Valmiera, Latvia
  • Romania
      • Bucharest, Romania
      • Cluj, Romania
      • Oradea, Romania
      • Tg. Mures, Romania
      • Timisoara, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Saratov, Russian Federation
      • Yaroslavl, Russian Federation
  • Ukraine
      • Chernivtsy, Ukraine
      • Dniepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Simferopol, Ukraine
  • United States
    • Florida
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Tampa, Florida, United States, 33613
        • Florida Medical Clinic-Tampa Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Dayton, Ohio, United States, 45415
        • Dayton Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
  • Mayo score of 6 to 10 points with moderate to severe disease on endoscopy

  • Subjects on the following medications;

    1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
    2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
    3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
    4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

  • Anti-TNF therapy within 8 weeks before study drug administration
  • Contraindication to colonoscopy or sigmoidoscopy
  • Primary or secondary immunodeficiency
  • Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
  • History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
  • Evidence of acute or chronic infection
  • Clinically significant disease requiring medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
sterile saline for injection
Biological: sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
Experimental: 1
MDX-1100 for injection
Biological: MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mayo score at Day 57 compared with Screening
Time Frame: Day 57
Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
the remission rate
Time Frame: Day 57
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX1100-06
  • IM129-004 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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