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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00873561 | A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 188 | — | — | Dec 1, 2001 | Jul 1, 2006 | Apr 1, 2009 | 21 | Canada, Czechia +6 |
| Arm | Type | Description |
|---|---|---|
| 1 Experimental | ACTIVE_COMPARATOR | NBI-6024 0.1 mg |
| 2 Experimental | ACTIVE_COMPARATOR | NBI-6024 0.5 mg |
| 3 Experimental | ACTIVE_COMPARATOR | NBI-6024 1 mg |
| 4 placebo | NO_INTERVENTION | Placebo injection |
| Name | Type | Description |
|---|---|---|
| NBI-6024 | DRUG | 0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled. |
Inclusion Criteria: * Male or female between the age of 12 and 35 years, inclusive (changed to between the age of 10 and 35 years, inclusive, under Amendment 2) * If female of childbearing potential, patient must use an acceptable method of birth control prior to and for 30 days post study * Adult ...