Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: MEDI-551
Product Code: MEDI-551
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: MEDI-551
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Confirmed Relapsing-Remitting Multiple Sclerosis (RRMS) according to revised 2010 McDonald criteria and brain lesions consistent with MS -At least 2 documented relapses within the past 3 years prior to screening or at least one documented relapse within 1 year prior to screening -Kurtzke Expanded Disability Status Scale (EDSS) between 0.0 and 5.0 at screening -At least 1 but not more than 15 gadolinium enhancing lesion(s)by cranial MRI at screening -Subjects that have 0-15 gadolinium enhancing lesion(s) - Male and female subjects must be willing to use effective methods of contraception -Willing to forego other forms of experimental treatment for RRMS during the study -Adequate peripheral venous access 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 512 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects who are unable to undergo cranial MRI scan -History of hypersensitivity to Gd containing MRI contrast agents -History of hypersensitivity to natural or recombinant interferon beta or any other component of the formulation of Avonex or discontinuation from treatment with Avonex due to associated adverse event -Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification for RRMS -Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid -Diagnosis of a non-RRMS neuro-inflammatory or demyelinating disease -Any concomitant disease that may require chronic treatment with IV or oral corticosteroids or immunosuppressants during the course of the study -History of primary immunodeficiency -Positive serology for hepatitis B and C -Any serious herpes infection at any time prior to randomization, including but not limited to disseminated herpes, herpes encephalitis, recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes -Any herpes zoster infection that has not completely resolved within 12 weeks prior to signing of the informed consent form -Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment -Known active, clinically significant infections -History of PML -History of cancer, apart from squamous or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months before randomization into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate the safety and tolerability of ascending doses of MEDI-551 in adult subjects with RRMS (Phase 1) 2) To compare the effect of MEDI-551 versus Avonex on the proportion of relapse free subjects at Week 48 (Phase 2) ;Secondary Objective: 1) To compare the effect of MEDI-551 versus Avonex on the mean cumulative Gd enhanced MRI T1 brain lesions at Weeks 24 and 48 (Phase 2) 2) To evaluate the effect of MEDI-551 on the Symbol Digit Modalities Test (SDMT; Phase 1/Phase 2) 3) To evaluate the PK and IM of MEDI-551 in the subject population (Phase 1/Phase 2) 4) To describe the PD effect of MEDI-551 by assessing B-cell depletion/repletion in the peripheral blood (Phase 1/Phase 2) 5) To evaluate the safety of MEDI-551 (Phase 2);Primary end point(s): Phase I - To evaluate the safety and tolerability of ascending doses of MEDI-551 in adult subjects with relapsing-remitting multiple sclerosis (RRMS) Phase II - To compare the effect of MEDI-551 versus Avonex on the proportion of relapse free subjects ;Timepoint(s) of evaluation of this end point: Phase I - Day 1 to Day 169 Phase II - Day 337 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To compare the effect of MEDI-551 versus Avonex on the mean cumulative gadolinium enhancing lesion(s) - To evaluate the effect of MEDI-551 on the Symbol Digit Modalities Test (SDMT) - To evaluate the pharmacokinetics (PK) and immunogenicity (IM) of MEDI-551 in the subject population - To describe the pharmacodynamic (PD) effects of MEDI-551 - To evaluate the safety of MEDI-551 ;Timepoint(s) of evaluation of this end point: Day 1 to Days 169/337 | — |
Countries
Austria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Enquiries
MedImmune LLC
Outcome results
None listed