Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000306516
Ethics application status
Not yet submitted
Date submitted
8/07/2006
Date registered
17/07/2006
Date last updated
17/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monotherapy Phase II Dose Ranging Study of DAC HYP in Relapsing Remitting Multiple Sclerosis
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
Secondary ID [1] 281 0
European Agency for the Evaluation of Medicinal Products (EMEA) European Clinical Trials (EUDRACT): EMEA EUDRACT No: 2006-001161-42
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 1278 0
Condition category
Condition code
Neurological 1365 1365 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daclizumab HYP (high yield process) 25mg, 100mg or 200mg, administered by subcutaneous injection every 4 weeks, for a duration of 12 months.
Intervention code [1] 1193 0
Treatment: Drugs
Comparator / control treatment
Placebo subcutaneous injection every 4 weeks, for a duration of 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 1866 0
The primary objective of this study is to determine the relationship between 3 different doses of daclizumab high yield process (DAC HYP) on brain lesion activity as measured by magnetic resonance imaging (MRI) in subjects with relapsing-remitting MS when compared to placebo. The primary endpoint is the total number of gadolinium (Gd) enhancing lesions over 5 brain MRI scans.
Timepoint [1] 1866 0
At Weeks 4, 8, 12, 16, and 20 (calculated as the sum of these 5 MRIs).
Secondary outcome [1] 3281 0
1) The number of new or newly-enlarging T2 hyperintense lesions
Timepoint [1] 3281 0
At Week 20 compared to baseline.
Secondary outcome [2] 3282 0
2) The volume of new T1 hypointense lesions
Timepoint [2] 3282 0
At Week 20 compared to baseline.
Secondary outcome [3] 3283 0
3) The change in total lesion volume of new and newly enlarging T2 hyperintense lesions.
Timepoint [3] 3283 0
At Week 20 compared to baseline.

Eligibility
Key inclusion criteria
Diagnosed with relapsing-remitting multiple sclerosis (according to McDonald criteria #1-4, Section 22), with a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, and who either have experienced at least 1 relapse within the 12 months prior to randomization with a cranial MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in this study.3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.4. History of abnormal laboratory results that, in the opinion of the investigator, are indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease that would preclude administration of DAC HYP.5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.7. 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.8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface antigen (HBsAg) at Screening.9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.10. Exposure to varicella zoster virus within 21 days before Screening.11. Any of the following abnormal blood tests at Screening:i.Hemoglobin < or = 9.0 g/dLii.Platelets < or = 100 x 109/Liii.Lymphocytes < or = 1.0 x 109/Liv.Neutrophils < or = 1.5 x 109/L12. Any previous treatment with DAC HYP or Zenapax®.13. Any of the following types of live virus vaccine from 4 weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines, however, by other members of the subject’s household does not affect the eligibility of patients to enroll or continue in the study.14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization.15. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.16. Prior treatment with the any of the following:· total lymphoid irradiation· cladribine· mitoxantrone· T-cell or T-cell receptor vaccination· any therapeutic monoclonal antibody, except natalizumab or rituximab17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to randomization.18. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:· natalizumab· cyclosporine· azathioprine· methotrexate· intravenous immunoglobulin (IVIg)· plasmapheresis or cytapheresis19. Prior treatment with any of the following within the 3 months prior to randomization:·SC or oral glatiramer acetate·IFN-alpha·IFN-beta (subjects who are positive for neutralizing antibodies to IFN beta may receive IFN-beta treatment up to 2 weeks prior to randomization)20. Treatment with any of the following medications within the 30 days prior to randomization:·IV corticosteroid treatment·oral corticosteroid treatment·4-aminopyridine or related products21. Female subjects considering becoming pregnant while in the study.22. Female subjects who are currently pregnant or breastfeeding.23. Previous participation in this study.24. Subjects, for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed.25. Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization.26.Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.27. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients assigned to placebo or 25mg DAC HYP will switch to 100 mg DAC HYP in part 2 of the study (week 20 thorugh 52) after experiencing a confirmed relapse
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1500 0
Commercial sector/Industry
Name [1] 1500 0
Biogen Idec
Country [1] 1500 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec
Address
Country
United States of America
Secondary sponsor category [1] 1317 0
None
Name [1] 1317 0
None
Address [1] 1317 0
Country [1] 1317 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2918 0
Royal Melbourne Hospital
Ethics committee address [1] 2918 0
Suite 30, 4th Floor, Royal Melbourne Hospital, Gratten Street, Parkeville VIC 3050
Ethics committee country [1] 2918 0
Australia
Date submitted for ethics approval [1] 2918 0
Approval date [1] 2918 0
Ethics approval number [1] 2918 0
Ethics committee name [2] 2919 0
Department of Medicine, University of Sydney
Ethics committee address [2] 2919 0
Department of Medicine, Room 479, 4th Floor, Blackburn Building, University of Sydney, NSW 2006
Ethics committee country [2] 2919 0
Australia
Date submitted for ethics approval [2] 2919 0
Approval date [2] 2919 0
Ethics approval number [2] 2919 0
Ethics committee name [3] 2920 0
Ethics committee address [3] 2920 0
207 Melbourne Street, North Adelaide SA 5006
Ethics committee country [3] 2920 0
Australia
Date submitted for ethics approval [3] 2920 0
Approval date [3] 2920 0
Ethics approval number [3] 2920 0
Ethics committee name [4] 2921 0
St Vincents Medical Centre
Ethics committee address [4] 2921 0
St Vincents Medical Centre Level 4, Suite 1, 55 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [4] 2921 0
Australia
Date submitted for ethics approval [4] 2921 0
Approval date [4] 2921 0
Ethics approval number [4] 2921 0
Ethics committee name [5] 2922 0
Department of Neurology, Austin Health
Ethics committee address [5] 2922 0
Department of Neurology, 6 North, Austin Tow, Austin Health, 145 Studley Road, Heidelberg Vic 3084
Ethics committee country [5] 2922 0
Australia
Date submitted for ethics approval [5] 2922 0
Approval date [5] 2922 0
Ethics approval number [5] 2922 0

Summary
Brief summary
The purpose of the study is to determine whether or not 3 different doses of DAC HYP are effective in decreasing the number of abnormal spots (lesions) on brain magnetic resonance imaging (MRI) scans and in delaying the progression of MS, and to test the safety of DAC HYP in patients with relapsing-remitting MS.
This is a double blind, parallel group study where subjects will receive either placebo, or Dac HYP 25mg, 100 mg or 200 mg every 4 weeks by subcutaneous injection for 52 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35673 0
Address 35673 0
Country 35673 0
Phone 35673 0
Fax 35673 0
Email 35673 0
Contact person for public queries
Name 10382 0
Lynn Sartori
Address 10382 0
Suite 2, Level 4, 123 Epping Road
North Ryde NSW 2113
PO Box 380, North Ryde BC NSW 1670
Country 10382 0
Australia
Phone 10382 0
(61) (0)2 8875 3907
Fax 10382 0
Fax: (61) (0)2 9889 1162
Email 10382 0
Lynn.Sartori@BiogenIdec.com
Contact person for scientific queries
Name 1310 0
Lynn Sartori
Address 1310 0
Suite 2 Level 4 123 Epping Road
North Ryde NSW 2113
PO Box 380 North Ryde BC NSW 1670
Country 1310 0
Australia
Phone 1310 0
(61) (0)2 8875 3907
Fax 1310 0
Fax: (61) (0)2 9889 1162
Email 1310 0
Lynn.Sartori@BiogenIdec.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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