Status:
COMPLETED
Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Collaborating Sponsors:
AbbVie
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are ...
Eligibility Criteria
Inclusion
- Key
- Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
- Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
- Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
- Key
Exclusion
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- History of malignancy
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- History of abnormal laboratory results based on investigator judgment
- History of human immunodeficiency virus (HIV) or other immunodeficient conditions
- History of drug or alcohol abuse within the 2 years prior to randomization
- An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
- Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
- Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
- Exposure to varicella zoster virus within 21 days before Screening.
- Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase \>2 times the upper limit of normal (ULN) and serum creatinine \>ULN.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT00390221
Start Date
February 1 2008
End Date
August 1 2011
Last Update
July 11 2016
Active Locations (56)
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1
Research Site
Brno, Czechia
2
Research Site
Olomouc, Czechia
3
Research Site
Pilsen, Czechia
4
Research Site
Teplice, Czechia