Multicentre, 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. - SELECT

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2006-001161-42-CZ
• Date of registration: 25/08/2006
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Ltd.
• Public title: Multicentre, 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. - SELECT
• Scientific title: Multicentre, 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. - SELECT
• Date of first enrolment: 30/11/2006
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001161-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Germany, Hungary, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Must give written informed consent and any authorizations required by local law
2. Must be 18 to 55 years of age, inclusive, at the time of informed consent.
3. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald
criteria #1-4
4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
5. Must meet either of the following 2 criteria:
a) Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to
obtain a current scan if a scan performed previously is available from the subject’s
history; if a scan is not available from the subject’s history, then the baseline scan
may be used). For inclusion purposes, a relapse is defined as neurologic signs and/or
symptoms documented by a neurologist in the medical record and of at least 24 hours duration to be determined by the Investigator or the Treating Neurologist. Time since relapse should be measured from the time of relapse onset, OR
b) Show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization (if scan is not available from the subject’s history,
then baseline scan may be used).
6. Must be disqualified from standard treatment for MS (sites in Poland only). Candidates in Poland must be from one of the following patient populations:
• Patients who rejected standard treatment for MS,
• Patients with contraindications for using standard treatment for MS,
• Patients for whom standard treatment for MS has proven ineffective,
• Patients who are on the waiting list for state-funded standard treatment for MS, but who will not receive standard treatment for the duration of the study (15 months).
7. Male subjects and female subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue
contraception for 4 months after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
2. 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:
• 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 × the
upper limit of normal (ULN)
• serum creatinine >ULN.
12. Any previous treatment with daclizumab 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 rituximab
17. 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 cytapheresis
19. 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 products
21. Female su

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple sclerosis (MS)
MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis

Intervention(s)

Product Name: DACLIZUMAB HYP
Pharmaceutical Form: Solution for injection
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary endpoint is the annualised relapse rate between baseline and week 52

Main Objective: Primary objective:
To determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and week 52

Secondary Objective: To determine whether DAC HYP is effective in:
- Reducing the number of new Gd-enhancing lesions over 5 brain MRI scans at weeks 8, 12, 16, 20 and 24 (calculated as the sum of these 5 MRI scans) in a subset of subjects
- Reducing the number of new or newly-enlarging T2 hyperintense lesions at week 52
- Reducing the proportion of relapsing subjects between baseline and week 52
-Improving quality of life as measured by the MSIS-29 physical score at week 24, compared to baseline

Secondary ID(s)

2006-001161-42-GB

Not available

205-MS-201