5256W-12 A Phase 1 Randomized Study of MEDI-551 in Subjects with Relapsing Forms of Multiple Scleros

A Phase 1 Randomized Study of MEDI-551 in Subjects with Relapsing Forms of Multiple Sclerosis

Type of Study
Neuroscience - Multiple Sclerosis
Short Description

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).

Status
Open
Principal Investigator
James Bowen, MD
Eligibility Notes

INCLUSION CRITERIA

  1. Age 18-65 years at the time of screening
  2. Confirmed relapsing forms of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and brain lesions consistent with MS on screening
  3. At least 1 documented relapse within the past 3 years prior to screening
  4. EDSS between 0.0 and 6.5 at screening
  5. Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan

EXCLUSION CRITERIA

  1. Subjects with impaired renal function
  2. Major surgery within 8 weeks of the screening visit
  3. Subjects who are unable to undergo cranial MRI scan
  4. A history of hypersensitivity to Gd-containing MRI contrast agents
  5. Has received at any time monoclonal antibodies or experimental B-cell depleting agents
  6. Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification for RRMS
  7. Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
  8. Diagnosis of a non-RRMS neuro-inflammatory or demyelinating disease
  9. 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
  10. Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol
Contact Name
Beena Gangadharan
Phone
206-320-2633
Alternate Phone
206-320-2647
Email
beena.gangadharan@swedish.org
Alternate Email
yuriko.courtney@swedish.org