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Keep this study
Lead
MedImmune LLC
This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening
At least 1 documented relapse within the past 3 years prior to screening
EDSS between 0.0 and 6.5 at screening
Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan
You may not be if
Subjects with impaired renal function
Major surgery within 8 weeks of the screening visit
Subjects who are unable to undergo cranial MRI scan
A history of hypersensitivity to Gd-containing MRI contrast agents
Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months
Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS
Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases
Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol
Clareo Health | Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
