Multiple sclerosis (MS) MedDRA version: 8.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
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 nu
Sponsors
Biogen Idec Ltd
Eligibility
Sex/Gender
All
Inclusion 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. 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
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 screening for active infection with hepatitis B virus or hepatitis C virus 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 x the upper limit of normal (ULN) • Serum creatinine >ULN • Any previous treatment with daclizumab or Zenapax® • 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. • Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization. • Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study. • 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 • Prior treatment with cyclophosphamide or rituximab within 1 year prior to randomization. • 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 • 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) • 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 • Female subjects considering becoming pregnant while in the study. • Female subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapes 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 MRIs) 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.;Primary end point(s): The primary endpoint is the annualised relapse rate between baseline and week 52 | — |
Countries
Czech Republic, Germany, Hungary, Sweden, United Kingdom
Outcome results
None listed