A Phase 1/2 study to test how effective different doses of MEDI-551 is for treating subjects with Relapsing-Remitting Multiple Sclerosis

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005475-16-GB
• Lead Sponsor: MedImmune LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 512

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified