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

May 31, 2016 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Teplice, Czech Republic
        • Research Site
  • Germany
      • Erlangen, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Osnabrueck, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Siofok, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • India
      • Andra-Pradeash, India
        • Research Site
      • Bangalore, India
        • Research Site
      • Chennai, India
        • Research Site
      • Kolkata, India
        • Research Site
      • Mumbai, India
        • Research Site
      • Rajasthan, India
        • Research Site
      • Visakhapatnam, India
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation
        • Research Site
      • Krasnoyarsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Omsk, Russian Federation
        • Research Site
      • Samara, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • St Petersburg, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine
        • Research Site
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
  • United Kingdom
      • London, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Plymouth, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Stoke-on-Trent, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
Drug: Placebo
Placebo SC injection
Experimental: 150 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Biological: BIIB019 (Daclizumab High Yield Process)
SC injection
Other Names:
  • DAC HYP
  • Daclizumab HYP
Experimental: 300 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Biological: BIIB019 (Daclizumab High Yield Process)
SC injection
Other Names:
  • DAC HYP
  • Daclizumab HYP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Annualized Relapse Rate Between Baseline and Week 52
Time Frame: Baseline through Week 52
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
Baseline through Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Time Frame: Week 8 through Week 24
Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.
Week 8 through Week 24
Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Time Frame: Week 52
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.
Week 52
Proportion of Participants Who Relapsed at Week 52
Time Frame: Week 52
Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.
Week 52
Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
Time Frame: Baseline and Week 52
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205-MS-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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