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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01462318 | An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis | PHASE3 | COMPLETED | 133 | — | — | Nov 1, 2011 | Jan 1, 2016 | Mar 14, 2017 | 19 | United States, Czechia +2 |
Participants with post-baseline (PB) ADAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).
Participants with PB NAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).
AUCinf of each of the following cytochrome P450 (CYP) isoenzyme substrates: midazolam (CYP3A), S-warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19). The AUC from zero to 12 hours (AUC0-12) was calculated for caffeine (CYP1A2).
| Arm | Type | Description |
|---|---|---|
| DAC HYP | EXPERIMENTAL | DAC HYP 150 mg by a subcutaneous (SC) injection using the pre-filled syringe (PFS) every 4 weeks for 24 weeks followed by a 20-week washout period. After completion of the washout period, participants may resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study will receive probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consists of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K is used to counteract warfarin's anticoagula nt effect prophylactically. |
| Name | Type | Description |
|---|---|---|
| Midazolam | DRUG | 5 mg |
| Caffeine | OTHER | 200 mg |
| S-warfarin | DRUG | 10 mg |
| Vitamin K | OTHER | 10 mg |
| Omeprazole | DRUG | 40 mg |
| Dextromethorphan | DRUG | 30 mg |
| BIIB019 (Daclizumab) | BIOLOGICAL | 150 mg in 1 ml PFS |
Key Inclusion Criteria: * Must have a confirmed diagnosis of RRMS according to McDonald criteria and previous cranial magnetic resonance imaging demonstrating lesion(s) consistent with MS * Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive * Must have had 1...