Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Registration Number
- NCT00072839
- Lead Sponsor
- Shire
- Brief Summary
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
- Detailed Description
The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description teduglutide teduglutide 0.05 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen Placebo placebo placebo solution injected subcutaneously daily into either thigh or abdomen. teduglutide 0.05 Teduglutide 0.05 dose teduglutide 0.05 mg/kg/d injected subcutaneously daily. teduglutide ALX-0600 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen teduglutide 0.1 teduglutide 0.1 mg dose 0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen teduglutide teduglutide 0.2 mg 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
- Primary Outcome Measures
Name Time Method The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8. 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers. 8 weeks of treatment
Trial Locations
- Locations (26)
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Northwestern University School of Medicine
🇺🇸Chicago, Illinois, United States
Visions Clinical Research - Sarasota
🇺🇸Sarasota, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Saint Joseph's Health System
🇺🇸Atlanta, Georgia, United States
Life Screening Centres
🇨🇦Toronto, Ontario, Canada
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Odyssey Research
🇨🇦Victoria, British Columbia, Canada
Venture Research
🇺🇸North Miami Beach, Florida, United States
Clinical Trials Management of Boca Raton
🇺🇸Boca Raton, Florida, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Rx Trials
🇺🇸Washington, District of Columbia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Pinnacle Trials
🇺🇸Atlanta, Georgia, United States
Asher Kornbluth, MD, PC
🇺🇸New York, New York, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Methodist Hospital/Baylor University
🇺🇸Houston, Texas, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
University of Louisville
🇺🇸Louisville, Kentucky, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
Dean Foundation Research Center
🇺🇸Madison, Wisconsin, United States