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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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).

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis, Relapsing Forms	Biological: MEDI-551 IV; Biological: MEDI-551 SC; Drug: Placebo IV; Drug: Placebo SC	Phase 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis
Study Start Date :	April 2012
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	June 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Safety and Tolerability [ Time Frame: Day 1 to Day 169 ]
   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 :

1. Pharmacokinetics of MEDI-551 [ Time Frame: Day 1 to Day 169 ]
   To evaluate the pharmacokinetics (PK) of MEDI-551 in the subject population (including but not limited to Cmax, Tmax, T1/2, AUC)
2. Pharmacodynamic Effect of MEDI-551 [ Time Frame: Day 1 to Day 169 ]
   To describe the pharmacodynamic (PD) effects of MEDI-551 as measured by the change in B cell count from baseline
3. Immunogenicity of MEDI-551 [ Time Frame: Day 1 to Day 169 ]
   To evaluate the immunogenicity (IM) of MEDI-551 in the subject population

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Locations

United States, Arizona
Research Site
Scottsdale, Arizona, United States
United States, California
Research Site
Long Beach, California, United States
Research Site
Sacramento, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Florida
Research Site
Tampa, Florida, United States
United States, New Jersey
Research Site
Marlton, New Jersey, United States
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States
United States, Tennessee
Research Site
Cordova, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
Poland
Research Site
Katowice, Poland
Research Site
Szczecin, Poland
Spain
Research Site
Barcelona, Spain
Research Site
Girona, Spain
Research Site
Sevilla, Spain
Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kyiv, Ukraine

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:	Armando Flor	MedImmune LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT01585766 History of Changes
Other Study ID Numbers:	CD-IA-MEDI-551-1102
First Posted:	April 26, 2012
Last Update Posted:	August 16, 2016
Last Verified:	August 2016

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