This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation.
Conditions
Interventions
Product Name: Daclizumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody
Concentration unit: mg/ml milligram
Sponsors
Protein Design Labs, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, 18 to 65 years of age, inclusive. 2. Diagnosis of MS by the McDonald criteria. 3. Score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding female 2. Non-ambulatory patient 3. Clinically significant abnormality on a screening electrocardiogram (ECG) 4. Malignancy within the past 5 years except for adequately treated non-melanoma skin carcinoma or in situ carcinoma of the cervix 5. A medical history of infection with the human immunodeficiency virus (HIV) 6. Positive serology for infection with hepatitis B or C virus (HBV or HCV) 7. Varicella or herpes zoster virus infection or any severe virus infection within 6 weeks before screening 8. Exposure to varicella zoster virus within 21 days before screening 9. Abnormal hematology, defined as any of the following: • Hemoglobin =1.6 mg/dL; AST and ALT >=2.5 x upper limit of normal [ULN]; alkaline phosphatase >=2.5 x ULN; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to randomization. 11. Use of any of the following: • 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 household contacts does not affect the eligibility of patients to enroll or continue in the study. • Systemic corticosteroids, adrenocorticotropic hormone, or plasma exchange within 4 weeks before the baseline MRI scan (no more than 72 hours before Day 0) • Azathioprine, mycophenolate mofetil, methotrexate, glatiramer acetate, or intravenous immune globulin within 6 months before randomization • An immunomodulatory agent within 6 months before randomization, except for interferon-beta products required per protocol • An investigational agent within 6 months before randomization unless this agent is non-immunomodulatory and the medical monitor or steering committee rules that its use is acceptable on the theoretical basis of a lapse of at least 5 serum half-lives since administration of the last possible dose • A monoclonal antibody (eg, Rituxan®/ Rituximab) within 6 months before randomization • Daclizumab at any time prior to randomization • Cladribine, mitoxantrone, cyclophosphamide, CamPath® (alemtuzumab), natalizumab (TYSABRI®/Antegren) or other drugs targeting alpha 4 integrin, total lymphoid irradiation, or bone marrow transplant at any time 12. Patients for whom MRI is contraindicated, ie, have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed 13. Primary progressive MS 14. Clinically unstable for 30 days before randomization (Patients who experience a relapse, with or without steroid treatment, during the screening period may be re-screened after 30 days.) 15. Elective surgery performed from 2 weeks prior to randomization or scheduled through Week 44 16. Infection (viral, fungal, bacterial) requiring hospitalization or IV antibiotics within 8 weeks before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of Study DAC-1012 is to evaluate the efficacy of daclizumab in patients who have active, relapsing forms of MS and are currently on IFN-beta therapy.;Secondary Objective: The secondary objectives are, in this study population of patients with active, relapsing forms of MS, to: 1) Determine the safety profile of daclizumab 2) Evaluate pharmacologic parameters (ie, pharmacokinetics and pharmacodynamics) 3) Evaluate immunogenicity (ie, development of antibodies to daclizumab [anti-DAC]) ;Primary end point(s): The primary efficacy endpoint is the number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed