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CompletedNCT00656890MDX1100-06Updated Oct 12, 2015

A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

A Phase 2 interventional study of sterile saline for injection and MDX-1100 in Ulcerative Colitis, sponsored by Bristol-Myers Squibb. Completed at 45 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • ulcerative colitis, rectal bleeding
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 110 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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;

    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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Placebo comparator
    2

    sterile saline for injection

    Biological: sterile saline for injection

  • Experimental
    1

    MDX-1100 for injection

    Biological: MDX-1100

Interventions

  • Biologicalsterile saline for injection

    10mg/kg/dose sterile saline injected every other week for a total of 4 doses

  • BiologicalMDX-1100

    10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses

06

What researchers measure

Primary outcomes

  1. Change in Mayo score at Day 57 compared with Screening

    Time frame: Day 57

Secondary outcomes

  1. the remission rate

    Time frame: Day 57

07

Study locations

45 sites
  • Advanced Medical Research Center
    Port Orange, Florida 32127, United States
  • Florida Medical Clinic-Tampa Clinic
    Tampa, Florida 33613, United States
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Dayton Science Institute
    Dayton, Ohio 45415, United States
  • Abbotsford, British Columbia V2S 3N5, Canada
  • Vancouver, British Columbia V5Z 1H2, Canada
  • Toronto, Ontario M3N 2V7, Canada
  • Olomouc, Czech Republic
  • Prague, Czech Republic
  • Strakonice, Czech Republic
  • Tabor, Czech Republic
  • Usti nad Labem, Czech Republic
  • Valasske Mezifici, Czech Republic
  • Budapest, Hungary
  • Debrecen, Hungary
  • Gyula, Hungary
  • Kaposvar, Hungary
  • Kecskemet, Hungary
  • Nagykanizsa, Hungary
  • Siofok, Hungary
  • Vac, Hungary
  • Zalaegerszeg, Hungary
  • Daugavpils, Latvia
  • Riga, Latvia
  • Valmiera, Latvia
  • Bucharest, Romania
  • Cluj, Romania
  • Oradea, Romania
  • Tg. Mures, Romania
  • Timisoara, Romania
  • Moscow, Russian Federation
  • Saratov, Russian Federation
  • Yaroslavl, Russian Federation
  • Chernivtsy, Ukraine
  • Dniepropetrovsk, Ukraine
  • Donetsk, Ukraine
  • Kharkiv, Ukraine
  • Kharkov, Ukraine
  • Kiev, Ukraine
  • Kyiv, Ukraine
  • Lviv, Ukraine
  • Simferopol, Ukraine
08

References and documents

Publications

  • Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5. PubMed 23461895 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00656890
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 11, 2008
Start date
Apr 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Oct 12, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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