Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing Forms
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: MEDI-551 30 MG-IV; MEDI-551 60 MG-SC; PLACEBO-IV-SC; MEDI-551 100 MG-IV; MEDI-551 300 MG-SC; MEDI-551 600 MG-IV
Intervention description: Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.; Participants received SC injection of 60 mg MEDI-551 on Day 1.; Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1; Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.; Participants received SC injection of 300 mg MEDI-551 on Day 1.; Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MAb, B cell, depletion, RMS

Summary:

      The purpose of this study is to evaluate the safety and tolerability of ascending intravenous
      (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of
      multiple sclerosis (MS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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