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

Ulcerative Colitis Clinical Trial

— MDX1100-06  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656890
• Other study ID #: MDX1100-06
• Secondary ID: IM129-004
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: September 23, 2015
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
• MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses

Locations

Country	Name	City	State
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Dayton Science Institute	Dayton	Ohio
United States	Mount Sinai School of Medicine	New York	New York
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Florida Medical Clinic-Tampa Clinic	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Hungary,  Latvia,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mayo score at Day 57 compared with Screening		Day 57	No
Secondary	the remission rate		Day 57	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm