Status:
COMPLETED
An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 syri...
Detailed Description
Following a screening period, participants will receive DAC HYP over a 24-week treatment period (6 monthly injections) and then enter a 20-week washout period for assessment of immunogenicity, PK, pha...
Eligibility Criteria
Inclusion
- Key
- 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 or more clinical relapses within the previous 2 years
- Women of child bearing potential must be willing to practice effective contraception during the study and 4 months after the last dose
- Key
Exclusion
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease
- Female subjects who are currently pregnant or breastfeeding
- Key Inclusion criteria for 3-Year Treatment Extension:
- To be eligible for participation in the 3-year treatment extension, participants must meet the following eligibility criteria at the time of reinitiation of DAC HYP:
- Must have been compliant with the 205MS302 (NCT01462318) protocol during the initial 24-week treatment period and the 20-week washout period in the opinion of the Investigator
- Must resume DAC HYP treatment ≤12 weeks after completion of the washout period (i.e., ≤12 weeks after their Week 44 visit).
- Participants who are currently receiving an approved IFN ß preparation must discontinue interferon (IFN) ß treatment at the time of reinitiation of DAC HYP dosing (no washout is required).
- Key Inclusion criteria for the TP-DI Sub-study:
- To be eligible for participation in the TP-DI Sub-Study, subjects must meet the following eligibility criteria at the Screening Visit at Week 40:
- Must have been compliant with the 205MS302 (NCT01462318) protocol during the initial 24-week treatment period and through Week 40 of the 20-week washout period in the opinion of the Investigator.
- Must agree to resume DAC HYP treatment ≤12 weeks after completion of the washout period (i.e., ≤12 weeks after their Week 44 visit).
- Must have normal liver function test results (total bilirubin ≤1.5 × upper limit of normal (ULN), alanine aminotransferase/aspartate aminotransferase ≤2 × ULN, and prothrombin time/partial thromboplastin time ≤1.2 × ULN).
- Must have normal renal function as estimated creatinine clearance \>60 mL/min (Cockcroft-Gault formula).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01462318
Start Date
November 1 2011
End Date
January 1 2016
Last Update
March 14 2017
Active Locations (19)
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1
Research Site
Centennial, Colorado, United States, 80112
2
Research Site
Washington D.C., District of Columbia, United States, 20057
3
Research Site
Lake Barrington, Illinois, United States, 60010
4
Research Site
Lexington, Kentucky, United States, 40513