Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
This study is currently recruiting participants.
Verified by Medarex, April 2008
Sponsored by: Medarex
Information provided by: Medarex
ClinicalTrials.gov Identifier: NCT00656890
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Biological: sterile saline for injection
Biological: MDX-1100
Phase II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Medarex:

Primary Outcome Measures:
  • Change in Mayo score at Day 57 compared with Screening [ Time Frame: Day 57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the remission rate [ Time Frame: Day 57 ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: April 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Placebo Comparator
sterile saline for injection
Biological: sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
1: Experimental
MDX-1100 for injection
Biological: MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses

Detailed Description:

This is a Phase2, double-blind, placebo-controilled, randomized, multicenter, multi-dose study of MDX-1100 (anti-CXCL10 human monoclonal antibody) in subjects with active UC experiencing flare. All subjects will have active disease while on a 5-ASA containing medication and are either on stable doses of corticosteroids and/or azathioprine or 6-mercaptopurine, or who have previously been on these medications but could not tolerate them. Flare is defined as a Mayo score of 6 to 10 with moderate to severe disease activity on endoscopy (Mayo endoscopic subscore of at least 2) within 2 weeks of receiving study drug administa=ration. Doses of permitted concomitant medications (corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), and 5-aminosalicylates (5-ASA) containing compounds) should remain constant during the course of the study.

Subjects will be randomized to receive placebo or MDX-1100 by intravenous (i.v.) infusion at 10 mg/kg on Days 1, 15, 29, and 43.All subjects will be seen in the clinic at regular intervals up to Day 85 for safety, efficacy, pharmacokinetic, and/or pharmacodynamic assessments. All subjects will be contacted 70 days after the last dose of study drug.

Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, physical examinations, immunogenicity assessments, chest x-ray, electrocardiograms, and the incidence and severity of treatment emergent adverse events.

The primary clinical assessment of activity will be determined by the change in Mayo score at Day 57 compared with Screening. Secondary endpoints include determination of remission rate by the mayo score at Day 57, evaluation of mucosal healing and change from baseline in the IBDQ score.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Active UC (as defined in Appendix 3) on 5-ASA therapy and also treated with 6-MP and/or corticosteroids or who have previously been treated with AZA, 6-MP or corticosteroids and could not tolerate them
  • Mayo score of 6 to 10 points with moderate to severe disease on endoscopy (Mayo score of at least 2) performed ≤ 14 days of study drug administration
  • Subjects on the following medications may be enrolled into the study if the medications were according to the following schedules prior to study drug administration and if no changes are anticipated during the study;

    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)
  • Subjects using rectal medications must have visible disease on sigmoidoscopy at ≥ 20 cm
  • Screening laboratory values must meet certain criteria:
  • Women must be postmenopausal (> 12 months without menses) or surgically sterile (e.g., by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (e.g., oral contraceptives, intrauterine device (IUD), double barrier method of condom and spermicidal) for at least 4 weeks prior to study drug administration and agree to continue contraception for the duration of their participation in the study; and
  • Sexually active male subjects must use a barrier method of contraception during the duration of the study.

Exclusion Criteria:

  • Anti-TNF therapy within 8 weeks before study drug administration
  • Any experimental therapy more therapy ≤ 4 weeks before study drug administration
  • Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins ≤ 8 weeks prior to study treatment
  • Presence of Cushing's syndrome
  • Toxic megacolon or fulminant disease likely to require colectomy
  • 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
  • Major psychiatric disease (subjects with stable depression receiving appropriate management will be permitted in the study);
  • Evidence of acute or chronic infection as evidenced by:
  • stool culture positive for pathogens and/or Clostridium difficile toxin
  • findings on Screening chest radiography such as pulmonary infiltrate(s) or adenopathy
  • current treatment for tuberculosis infection, clinical or radiological evidence of active TB, or for subjects in North America, a positive PPD without prior prophylaxis
  • Herpes zoster ≤ 3 months prior to study drug administration
  • active infectious disease requiring i.v. antibiotics within 4 weeks prior to study treatment or oral antibiotics at the time of enrollment
  • HIV or AIDS
  • positive tests for HBV, or HCV indicating active or chronic infection
  • Clinically significant cardiac disease requiring medication, unstable angina, myocardial within 6 months, or congestive heart failure
  • Arrhythmia requiring active therapy, with the exception of clinically insignificant or minor conduction abnormalities
  • History of cerebrovascular disease requiring medication/treatment
  • Anticoagulation therapy or a known bleeding disorder
  • Seizure disorder requiring active therapy
  • Known drug or alcohol abuse
  • Pregnant or nursing
  • Any underlying medical condition that in the Principal Investigator's opinion will make the of study drug hazardous to the subject or would obscure the interpretation of treatment efficacy or safety; or
  • Inability or unwillingness to return for Follow-up visits and comply with study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656890

Contacts
Contact: James Bainbridge 908.479.2364 jbainbridge@medarex.com
Contact: Einav Leberknight 908.479.2570 eleberknight@medarex.com

Locations
United States, Florida
Advanced Medical Research Center Recruiting
Port Orange, Florida, United States, 32127
Principal Investigator: Ammar Hemaidan, MD            
United States, Maryland
Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Jennifer Bell     301-652-5520        
Principal Investigator: Robert Hardi, MD            
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Caroline Vemulapalli     314-362-9093        
Principal Investigator: Christian D Stone, MD            
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Bradford Bernert     212-659-8375        
Principal Investigator: Lloyd F Mayer, MD            
United States, Ohio
Dayton Science Institute Recruiting
Dayton, Ohio, United States, 45415
Contact: Gigi Guerrero     937-293-4424 ext 6153        
Principal Investigator: Teressa J Patrick, MD            
Sponsors and Collaborators
Medarex
Investigators
Study Director: Michael Yellin, MD Medarex
  More Information

Responsible Party: Medarex, Inc ( Medarex, Inc )
Study ID Numbers: MDX1100-06
Study First Received: April 4, 2008
Last Updated: October 10, 2008
ClinicalTrials.gov Identifier: NCT00656890  
Health Authority: United States: Food and Drug Administration

Keywords provided by Medarex:
ulcerative colitis, rectal bleeding

Study placed in the following topic categories:
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Hemorrhage
Intestinal Diseases
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009