Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
NCT ID: NCT01585766
Last Updated: 2018-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2012-04-24
2016-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MEDI-551 30 MG-IV
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
MEDI-551 30 MG-IV
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
MEDI-551 60 MG-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
MEDI-551 60 MG-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
MEDI-551 100 MG-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
MEDI-551 100 MG-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
MEDI-551 300 MG-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
MEDI-551 300 MG-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
MEDI-551 600 MG-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
MEDI-551 600 MG-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1.
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1
Interventions
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MEDI-551 30 MG-IV
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
MEDI-551 60 MG-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1
MEDI-551 100 MG-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
MEDI-551 300 MG-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
MEDI-551 600 MG-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Armando Flor
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Long Beach, California, United States
Research Site
Sacramento, California, United States
Research Site
Denver, Colorado, United States
Research Site
Tampa, Florida, United States
Research Site
Marlton, New Jersey, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cordova, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Katowice, , Poland
Research Site
Szczecin, , Poland
Research Site
Barcelona, , Spain
Research Site
Girona, , Spain
Research Site
Seville, , Spain
Research Site
Donetsk, , Ukraine
Research Site
Kyiv, , Ukraine
Countries
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Other Identifiers
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CD-IA-MEDI-551-1102
Identifier Type: -
Identifier Source: org_study_id
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