Multiple Sclerosis
Conditions
Keywords
Relapsing-remitting, Secondary progressive, Relapsing forms
Brief summary
This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
Interventions
DRUGABT-555
Intravenous Infusion
OTHERPlacebo
Intravenous Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR * Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR * Treatment naïve with established MS diagnosis per criteria by a neurologist. * Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria * Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive. * Brain MRI scan at Screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with MS, which would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF collection
Exclusion criteria
* Diagnosis of primary progressive MS. * Anticipated maintenance immunomodulator change, either agent or dose * An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization * Participants for whom MRI is contraindicated * Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures * Findings on brain MRI scan indicating any clinically significant brain abnormality other than MS * Contraindication for lumbar puncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration curve (AUC) of ABT-555 | Day 1 to Day 176 |
| Number and percentage of participants reporting adverse events | Throughout study from Day 1 to Day 176 |
| Concentration of anti-drug antibody (ADA) titers of ABT-555 | Day 1 to Day 176 |
| Time to Maximum observed plasma concentration (Tmax) of ABT-555 | Day 1 to Day 176 |
| Maximum observed plasma concentration (Cmax) of ABT-555 | Day 1 to Day 176 |
Secondary
| Measure | Time frame |
|---|---|
| Total number of new Gadolinium-enhancing T1 lesions | Throughout study from Day 0 to Day 113 |
| Percentage of participants who experience relapse and disability progression | Throughout the study to Day 176 |
| Lesion volume of new, newly enlarging T2 hyperintense lesions | Throughout study from Day 0 to Day 113 |
| Number of new, newly-enlarging T2 hyperintense lesions | Throughout study from Day 0 to Day 113 |
Countries
United States
Outcome results
None listed