CompletedPhase 2

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

United States110 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

What they're measuring

Change in Mayo score at Day 57 compared with Screening

Timeframe: Day 57

Trial details

NCT IDNCT00656890

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

View on ClinicalTrials.gov More Ulcerative Colitis trials