A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
- Registration Number
- NCT02601885
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Placebo Participants will receive multiple doses of ABT-555 or placebo Group 3 Placebo Participants will receive multiple doses of ABT-555 or placebo Group 2 Placebo Participants will receive multiple doses of ABT-555 or placebo Group 2 ABT-555 Participants will receive multiple doses of ABT-555 or placebo Group 3 ABT-555 Participants will receive multiple doses of ABT-555 or placebo Group 1 ABT-555 Participants will receive multiple doses of ABT-555 or placebo
- Primary Outcome Measures
Name Time Method Number and percentage of participants reporting adverse events Throughout study from Day 1 to Day 176 Area under the concentration curve (AUC) 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 Concentration of anti-drug antibody (ADA) titers of ABT-555 Day 1 to Day 176
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
Parexel International
🇺🇸Baltimore, Maryland, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Integrated Neurology Services
🇺🇸Alexandria, Virginia, United States
MIND
🇺🇸Farmington Hills, Michigan, United States
Tri-State Mountain Neurology
🇺🇸Johnson City, Tennessee, United States