Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00072839 | Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease | PHASE2 | COMPLETED | 100 | — | — | Nov 12, 2003 | Jul 28, 2005 | May 25, 2021 | 26 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | placebo solution injected subcutaneously daily into either thigh or abdomen. |
| teduglutide 0.05 | EXPERIMENTAL | teduglutide 0.05 mg/kg/d injected subcutaneously daily. |
| teduglutide 0.1 | EXPERIMENTAL | 0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen |
| teduglutide | EXPERIMENTAL | 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen |
| Name | Type | Description |
|---|---|---|
| ALX-0600 | DRUG | teduglutide |
| placebo | DRUG | placebo solution injected subcutaneously |
| teduglutide 0.05 | DRUG | 0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen |
| teduglutide 0.2 mg | DRUG | 0.2 mg/kg/d subcutaneously injected into thigh or abdomen |
| Teduglutide 0.05 dose | DRUG | 0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen |
| teduglutide 0.1 mg dose | DRUG | 0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen |
Inclusion Criteria 1. Men and women, 18 years of age and older 2. Signed and dated informed consent to participate before any study-related procedures are performed 3. Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed 4. A Crohn's Disease Activity Index (CDAI...