Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01585766
First received: April 9, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis, Relapsing Forms
Biological: MEDI-551 IV
Biological: MEDI-551 SC
Drug: Placebo IV
Drug: Placebo SC
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of ascending IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS through the assessment of treatment-emergent adverse events and serious adverse events


Secondary Outcome Measures:
  • Pharmacokinetics of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetics (PK) of MEDI-551 in the subject population (including but not limited to Cmax, Tmax, T1/2, AUC)

  • Pharmacodynamic Effect of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To describe the pharmacodynamic (PD) effects of MEDI-551 as measured by the change in B cell count from baseline

  • Immunogenicity of MEDI-551 [ Time Frame: Day 1 to Day 169 ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity (IM) of MEDI-551 in the subject population


Estimated Enrollment: 28
Study Start Date: April 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-551 Dosage 1
Dosage Level 1 x 2 MEDI-551 IV
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
Experimental: MEDI-551 Dosage 2
Dosage Level 2 x 2 MEDI-551 IV
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
Experimental: MEDI-551 Dosage 3
Dosage Level 3 x 1 MEDI-551 SC
Biological: MEDI-551 SC
Associated Dosage Level X 1 MEDI-551 SC
Experimental: MEDI-551 Dosage 4
Dosage Level 4 x 1 MEDI-551 SC
Biological: MEDI-551 SC
Associated Dosage Level X 1 MEDI-551 SC
Experimental: MEDI-551 Dosage 5
Dosage Level 5 x 2 MEDI-551 IV
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
Placebo Comparator: Placebo IV
Placebo IV x 2
Drug: Placebo IV
Placebo IV x 2
Placebo Comparator: Placebo SC
Placebo SC x 1
Drug: Placebo SC
Placebo SC x 1

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585766

  Show 27 Study Locations
Sponsors and Collaborators
MedImmune LLC
PPD
Investigators
Study Director: Medical Monitor MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01585766     History of Changes
Other Study ID Numbers: CD-IA-MEDI-551-1102
Study First Received: April 9, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
MAb, B cell, depletion, RMS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014