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Clinical Trials/NCT00656890
NCT00656890CompletedPhase 2

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

Bristol-Myers Squibb51 sites in 8 countries110 target enrollmentStarted: April 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
110
Locations
51
Primary Endpoint
Change in Mayo score at Day 57 compared with Screening
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Mayo score at Day 57 compared with Screening

Time Frame: Day 57

Secondary Outcomes

  • the remission rate(Day 57)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (51)

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A Study of MDX-1100 in Subjects With... | Clinical Trial