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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— SELECT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390221
• Other study ID #: 205-MS-201
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: October 13, 2014
• Start date: February 2008
• Est. completion date: August 2011

Study information

• Verified date: October 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: State Pharmacological Center - Ministry of HealthCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIndia: Drugs Controller General of IndiaTurkey: Ministry of HealthGermany: Paul-Ehrlich-InstitutRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether Daclizumab High Yield Process, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether Daclizumab High Yield Process 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 relapses and improving quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

• 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 × 109/L, Lymphocytes =1.0 × 109/L, Neutrophils =1.5 × 109/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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• BIIB019 (Daclizumab High Yield Process)
SC injection

Drug:
• Placebo
Placebo SC injection

Locations

Country	Name	City	State
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Teplice
Germany	Research Site	Berlin
Germany	Research Site	Erlangen
Germany	Research Site	Marburg
Germany	Research Site	Osnabrueck
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Debrecen
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kecskemet
Hungary	Research Site	Miskolc
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Siofok
Hungary	Research Site	Zalaegerszeg
India	Research Site	Andra-Pradeash
India	Research Site	Bangalore
India	Research Site	Chennai
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	Pune
India	Research Site	Rajastan
India	Research Site	Vishakhapatnam
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Coordinating Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Warsaw
Poland	Research Site	Warszawa
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
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	St Petersburg
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Yaroskavi
Ukraine	Research Site	Chernivtsy
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Poltava
Ukraine	Research Site	Zaporozhye
Ukraine	Research Site	Zaporozhye
United Kingdom	Research Site	London
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Stoke-on-Trent

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	AbbVie

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  India,  Poland,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Relapse Rate	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 will be calculated as the total number of relapses experienced in the group divided by the number of days up to Week 52, and the ratio multiplied by 365.	1 year	No
Secondary	Number of new Gd-enhancing lesions		Weeks 8, 12, 16, 20, and 24	No
Secondary	Percentage of participants with relapses		1 year	No
Secondary	Change from Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 physical score	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.	Baseline and Week 52	No
Secondary	Number of new or newly-enlarging T2 hyperintense lesions		1 year	No

External Links

•   (MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)
•   (The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)