Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00390221
• Date of registration: 17/10/2006
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis SELECT
• Scientific title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: February 2008
• Target sample size: 621
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00390221
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Czech Republic, Former Serbia and Montenegro, Germany, Hungary, India, Poland, Russian Federation, Sweden, Turkey, Ukraine, United Kingdom

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: Placebo

Biological: BIIB019 (Daclizumab High Yield Process)

Primary Outcome(s)

Adjusted Annualized Relapse Rate Between Baseline and Week 52 [Time Frame: Baseline through Week 52]

Secondary Outcome(s)

Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52 [Time Frame: Baseline and Week 52]

Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24 [Time Frame: Week 8 through Week 24]

Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52 [Time Frame: Week 52]

Proportion of Participants Who Relapsed at Week 52 [Time Frame: Week 52]

Secondary ID(s)

205-MS-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie

Results

• Results available: Yes
• Date Posted: 11/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00390221