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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-18

Study Completion Date

2018-04-20

Brief Summary

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

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 2

Participants will receive multiple doses of ABT-555 or placebo

Group Type EXPERIMENTAL

ABT-555

Intervention Type DRUG

Intravenous Infusion

Placebo

Intervention Type OTHER

Intravenous Infusion

Group 3

Participants will receive multiple doses of ABT-555 or placebo

Group Type EXPERIMENTAL

ABT-555

Intervention Type DRUG

Intravenous Infusion

Placebo

Intervention Type OTHER

Intravenous Infusion

Group 1

Participants will receive multiple doses of ABT-555 or placebo

Group Type EXPERIMENTAL

ABT-555

Intervention Type DRUG

Intravenous Infusion

Placebo

Intervention Type OTHER

Intravenous Infusion

Interventions

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ABT-555

Intravenous Infusion

Intervention Type DRUG

Placebo

Intravenous Infusion

Intervention Type OTHER

Other Intervention Names

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Elezanumab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No