Clinical trial NCT02601885: A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Official title: An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Relapsing-remitting
Secondary progressive
Relapsing forms
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number and percentage of participants reporting adverse events
timeFrame: Throughout study from Day 1 to Day 176
measure: Concentration of anti-drug antibody (ADA) titers of ABT-555
timeFrame: Day 1 to Day 176
measure: Time to Maximum observed plasma concentration (Tmax) of ABT-555
timeFrame: Day 1 to Day 176
measure: Maximum observed plasma concentration (Cmax) of ABT-555
timeFrame: Day 1 to Day 176
measure: Area under the concentration curve (AUC) of ABT-555
timeFrame: Day 1 to Day 176
Secondary outcomes:
measure: Percentage of participants who experience relapse and disability progression
timeFrame: Throughout the study to Day 176
measure: Lesion volume of new, newly enlarging T2 hyperintense lesions
timeFrame: Throughout study from Day 0 to Day 113
measure: Number of new, newly-enlarging T2 hyperintense lesions
timeFrame: Throughout study from Day 0 to Day 113
measure: Total number of new Gadolinium-enhancing T1 lesions
timeFrame: Throughout study from Day 0 to Day 113
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Baltimore
country: United States
facility: Parexel International
state: Maryland
city: Farmington Hills
country: United States
facility: MIND
state: Michigan
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Johnson City
country: United States
facility: Tri-State Mountain Neurology
state: Tennessee
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Alexandria
country: United States
facility: Integrated Neurology Services
state: Virginia
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: