A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Elezanumab
Repulsive guidance molecule A inhibitor
Placebo or sham
- Placebo
What it measured
Main measures
Number and percentage of participants reporting adverse events
Throughout study from Day 1 to Day 176
SafetyConcentration of anti-drug antibody (ADA) titers of ABT-555
Day 1 to Day 176
Immune responseTime to Maximum observed plasma concentration (Tmax) of ABT-555
Day 1 to Day 176
How the body handles the medicineMaximum observed plasma concentration (Cmax) of ABT-555
Day 1 to Day 176
How the body handles the medicineArea under the concentration curve (AUC) of ABT-555
Day 1 to Day 176
How the body handles the medicine
Other measures (4)
Percentage of participants who experience relapse and disability progression
Throughout the study to Day 176
Disability progressionRelapsesLesion volume of new, newly enlarging T2 hyperintense lesions
Throughout study from Day 0 to Day 113
MRI lesionsNumber of new, newly-enlarging T2 hyperintense lesions
Throughout study from Day 0 to Day 113
MRI lesionsTotal number of new Gadolinium-enhancing T1 lesions
Throughout study from Day 0 to Day 113
MRI lesions
Who could take part
Relapsing and progressive · 18 to 60
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
Papers
Loading reviews and guidelines…
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History
Started
Oct 2016
Main results due
Apr 2018
Finished
Apr 2018
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