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NCT01462318 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
NCT01462318: Completed Phase 3 study, sponsored by Biogen.
NCT01462318 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 133 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01462318, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).
Primary Outcome
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).
Interventions
- DRUG Midazolam
- DRUG Omeprazole
- OTHER Caffeine
- DRUG S-warfarin
- OTHER Vitamin K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01462318 record still lists
NCT01462318 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT01462318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01462318 about?
NCT01462318 is a clinical study titled "An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis". The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectiv...
What is the current status of trial NCT01462318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2011-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01462318?
The interventions under investigation include: Midazolam (DRUG), Omeprazole (DRUG), Caffeine (OTHER), S-warfarin (DRUG), Vitamin K (OTHER).
Who is sponsoring clinical trial NCT01462318?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01462318's enrollment target sits among peer trials
133 1588th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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