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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656890

Acronym

MDX1100-06

Enrollment

110

Registered

2008-04-11

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis, rectal bleeding

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Mayo score at Day 57 compared with Screening	Day 57

Secondary

Measure	Time frame
the remission rate	Day 57

Countries

Canada, Czechia, Hungary, Latvia, Romania, Russia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026