A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).

Key facts

Study ID

NCT02601885

Run by

AbbVie

People needed

20

Starts

2016-10-18

Expected to finish

2018-04-20

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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