An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
Completed · Phase 3
Conditions studied: Relapsing-Remitting Multiple Sclerosis
In brief
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).
Key facts
- Study ID
- NCT01462318
- Run by
- Biogen
- People needed
- 133
- Starts
- 2011-11-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-03-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Centennial, Colorado, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Lake Barrington, Illinois, United States
- Research Site — Lexington, Kentucky, United States
- Research Site — Farmington Hills, Michigan, United States
- Research Site — Dayton, Ohio, United States
- Research Site — Franklin, Tennessee, United States
- Research Site — Brno, Czechia
- Research Site — Jihlava, Czechia
- Research Site — Ostrava, Czechia
- Research Site — Pardubice, Czechia
- Research Site — Teplice, Czechia
- Research Site — Veszprém, Korhazu 1, Hungary
- Research Site — Budapest, Hungary
- Research Site — Debrecen, Hungary
- Research Site — Esztergom, Hungary
- Research Site — Székesfehérvár, Hungary
- Research Site — Katowice, Poland
- Research Site — Krakow, Poland
Full record on ClinicalTrials.gov
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