This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Compass Research LLC
Orlando, Florida, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Parexel International
Baltimore, Maryland, United States
MIND
Farmington Hills, Michigan, United States
Number and percentage of participants reporting adverse events
Time frame: Throughout study from Day 1 to Day 176
Concentration of anti-drug antibody (ADA) titers of ABT-555
Time frame: Day 1 to Day 176
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Time frame: Day 1 to Day 176
Maximum observed plasma concentration (Cmax) of ABT-555
Time frame: Day 1 to Day 176
Area under the concentration curve (AUC) of ABT-555
Time frame: Day 1 to Day 176
Percentage of participants who experience relapse and disability progression
Time frame: Throughout the study to Day 176
Lesion volume of new, newly enlarging T2 hyperintense lesions
Time frame: Throughout study from Day 0 to Day 113
Number of new, newly-enlarging T2 hyperintense lesions
Time frame: Throughout study from Day 0 to Day 113
Total number of new Gadolinium-enhancing T1 lesions
Time frame: Throughout study from Day 0 to Day 113
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Duke Univ Med Ctr
Durham, North Carolina, United States
Tri-State Mountain Neurology
Johnson City, Tennessee, United States
Clinical Trial Network
Houston, Texas, United States
Integrated Neurology Services
Alexandria, Virginia, United States