A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
MDX1100-06
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
2 other identifiers
interventional
110
8 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 12, 2015
September 1, 2015
1.4 years
April 4, 2008
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mayo score at Day 57 compared with Screening
Day 57
Secondary Outcomes (1)
the remission rate
Day 57
Study Arms (2)
2
PLACEBO COMPARATORsterile saline for injection
1
EXPERIMENTALMDX-1100 for injection
Interventions
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
Eligibility Criteria
You may qualify if:
- 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)
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
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
Unknown Facility
Abbotsford, British Columbia, V2S 3N5, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
Toronto, Ontario, M3N 2V7, Canada
Unknown Facility
Olomouc, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Strakonice, Czechia
Unknown Facility
Tábor, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Unknown Facility
Valasske Mezifici, Czechia
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Gyula, Hungary
Unknown Facility
Kaposvár, Hungary
Unknown Facility
Kecskemét, Hungary
Unknown Facility
Nagykanizsa, Hungary
Unknown Facility
Siófok, Hungary
Unknown Facility
Vác, Hungary
Unknown Facility
Zalaegerszeg, Hungary
Unknown Facility
Daugavpils, Latvia
Unknown Facility
Riga, Latvia
Unknown Facility
Valmiera, Latvia
Unknown Facility
Bucharest, Romania
Unknown Facility
Cluj-Napoca, Romania
Unknown Facility
Oradea, Romania
Unknown Facility
Tg. Mures, Romania
Unknown Facility
Timișoara, Romania
Unknown Facility
Moscow, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Yaroslavl, Russia
Unknown Facility
Chernivtsy, Ukraine
Unknown Facility
Dniepropetrovsk, Ukraine
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Simferopol, Ukraine
Related Publications (1)
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.
PMID: 23461895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 11, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-09