Phase 2
Completed N=621
Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00390221 ↗Enrolled (actual)
621
Serious AEs
18.2%
Results posted
Jul 2016
Primary outcomePrimary: Adjusted Annualized Relapse Rate Between Baseline and Week 52 — 0.458; 0.211; 0.230 relapses per person-years — p=<0.0001
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 to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Annualized Relapse Rate Between Baseline and Week 52 |
0.458; 0.211; 0.230 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24 |
4.79; 1.46; 1.03 | <0.0001 sig |
| SECONDARY Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52 |
8.13; 2.42; 1.73 | <0.0001 sig |
| SECONDARY Proportion of Participants Who Relapsed at Week 52 |
0.36; 0.19; 0.20 | 0.0003 sig |
| SECONDARY Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52 |
3.0; -1.0; 1.4 | 0.1284 |
Eligibility Criteria
Key Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00390221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.