Crohn's Disease
Conditions
Keywords
Crohn Disease, Crohn's Disease
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 sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
Interventions
0.1 mg/kg injected subcutaneously daily
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have completed participation in the Pilot Active Crohn's Disease Study. * Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions: * CDAI score greater than 220 * Stool samples not required * C-reactive protein levels are not an exclusion criterion
Exclusion criteria
* Subject must continue to meet all
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. | 12 weeks after start of study |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved. | 12 weeks after study start |
| The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study | 12 weeks after study start |
Countries
Canada, United States
Outcome results
None listed