NCT02601885

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

October 18, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

November 5, 2015

Last Update Submit

May 16, 2018

Conditions

Multiple Sclerosis

Keywords

Relapsing-remittingSecondary progressiveRelapsing forms

Outcome Measures

Primary Outcomes (5)

  • Number and percentage of participants reporting adverse events

    Throughout study from Day 1 to Day 176

  • Concentration of anti-drug antibody (ADA) titers 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

  • Area under the concentration curve (AUC) of ABT-555

    Day 1 to Day 176

Secondary Outcomes (4)

  • 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

  • Total number of new Gadolinium-enhancing T1 lesions

    Throughout study from Day 0 to Day 113

Study Arms (3)

Group 2

EXPERIMENTAL

Participants will receive multiple doses of ABT-555 or placebo

Drug: ABT-555Other: Placebo

Group 3

EXPERIMENTAL

Participants will receive multiple doses of ABT-555 or placebo

Drug: ABT-555Other: Placebo

Group 1

EXPERIMENTAL

Participants will receive multiple doses of ABT-555 or placebo

Drug: ABT-555Other: Placebo

Interventions

ABT-555DRUG

Intravenous Infusion

Also known as: Elezanumab
Group 1Group 2Group 3
PlaceboOTHER

Intravenous Infusion

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Compass Research LLC

Orlando, Florida, 32806, United States

Location

Rowe Neurology Institute

Lenexa, Kansas, 66214, United States

Location

Parexel International

Baltimore, Maryland, 21225, United States

Location

MIND

Farmington Hills, Michigan, 48334, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Tri-State Mountain Neurology

Johnson City, Tennessee, 37604, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Integrated Neurology Services

Alexandria, Virginia, 22310, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

elezanumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 11, 2015

Study Start

October 18, 2016

Primary Completion

April 20, 2018

Study Completion

April 20, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

US(8)