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

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: Parallel 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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

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


Enrollment:	56
Study Start Date:	April 2012
Study Completion Date:	June 2016
Primary Completion Date:	January 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 (Adult)
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

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


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:	August 15, 2016
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 23, 2016