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)
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Rx Trials
🇺🇸Washington, District of Columbia, United States
Clinical Trials Management of Boca Raton
🇺🇸Boca Raton, Florida, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Venture Research
🇺🇸North Miami Beach, Florida, United States
Visions Clinical Research - Sarasota
🇺🇸Sarasota, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Pinnacle Trials
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Health System
🇺🇸Atlanta, Georgia, United States
Scroll for more (16 remaining)Advanced Clinical Therapeutics🇺🇸Tucson, Arizona, United States