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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Biological: sterile saline for injection
* Biological: MDX-1100


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>sterile saline for injection | Biological: sterile saline for injection<br>* 10mg/kg/dose sterile saline injected every other week for a total of 4 doses<br>|
| Experimental: 1<br>MDX-1100 for injection | Biological: MDX-1100<br>* 10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mayo score at Day 57 compared with Screening |  | Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the remission rate |  | Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, rectal bleeding