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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-555
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Relapsing-remitting, Secondary progressive, Relapsing forms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Compass Research LLC
  • Rowe Neurology Institute
  • Parexel International
  • MIND
  • Duke Univ Med Ctr
  • Tri-State Mountain Neurology
  • Clinical Trial Network
  • Integrated Neurology Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 2

Group 3

Group 1

Arm Description

Participants will receive multiple doses of ABT-555 or placebo

Participants will receive multiple doses of ABT-555 or placebo

Participants will receive multiple doses of ABT-555 or placebo

Outcomes

Primary Outcome Measures

Number and percentage of participants reporting adverse events
Concentration of anti-drug antibody (ADA) titers of ABT-555
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Maximum observed plasma concentration (Cmax) of ABT-555
Area under the concentration curve (AUC) of ABT-555

Secondary Outcome Measures

Percentage of participants who experience relapse and disability progression
Lesion volume of new, newly enlarging T2 hyperintense lesions
Number of new, newly-enlarging T2 hyperintense lesions
Total number of new Gadolinium-enhancing T1 lesions

Full Information

First Posted
November 5, 2015
Last Updated
May 16, 2018
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02601885
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Relapsing-remitting, Secondary progressive, Relapsing forms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of ABT-555 or placebo
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of ABT-555 or placebo
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of ABT-555 or placebo
Intervention Type
Drug
Intervention Name(s)
ABT-555
Other Intervention Name(s)
Elezanumab
Intervention Description
Intravenous Infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Number and percentage of participants reporting adverse events
Time Frame
Throughout study from Day 1 to Day 176
Title
Concentration of anti-drug antibody (ADA) titers of ABT-555
Time Frame
Day 1 to Day 176
Title
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Time Frame
Day 1 to Day 176
Title
Maximum observed plasma concentration (Cmax) of ABT-555
Time Frame
Day 1 to Day 176
Title
Area under the concentration curve (AUC) of ABT-555
Time Frame
Day 1 to Day 176
Secondary Outcome Measure Information:
Title
Percentage of participants who experience relapse and disability progression
Time Frame
Throughout the study to Day 176
Title
Lesion volume of new, newly enlarging T2 hyperintense lesions
Time Frame
Throughout study from Day 0 to Day 113
Title
Number of new, newly-enlarging T2 hyperintense lesions
Time Frame
Throughout study from Day 0 to Day 113
Title
Total number of new Gadolinium-enhancing T1 lesions
Time Frame
Throughout study from Day 0 to Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Parexel International
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
MIND
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Tri-State Mountain Neurology
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Integrated Neurology Services
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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