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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02601885
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ABT-555 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 2
Participants will receive multiple doses of ABT-555 or placebo
Drug: ABT-555
Intravenous Infusion
Other Name: Elezanumab

Other: Placebo
Intravenous Infusion

Experimental: Group 3
Participants will receive multiple doses of ABT-555 or placebo
Drug: ABT-555
Intravenous Infusion
Other Name: Elezanumab

Other: Placebo
Intravenous Infusion

Experimental: Group 1
Participants will receive multiple doses of ABT-555 or placebo
Drug: ABT-555
Intravenous Infusion
Other Name: Elezanumab

Other: Placebo
Intravenous Infusion




Primary Outcome Measures :
  1. Number and percentage of participants reporting adverse events [ Time Frame: Throughout study from Day 1 to Day 176 ]
  2. Concentration of anti-drug antibody (ADA) titers of ABT-555 [ Time Frame: Day 1 to Day 176 ]
  3. Time to Maximum observed plasma concentration (Tmax) of ABT-555 [ Time Frame: Day 1 to Day 176 ]
  4. Maximum observed plasma concentration (Cmax) of ABT-555 [ Time Frame: Day 1 to Day 176 ]
  5. Area under the concentration curve (AUC) of ABT-555 [ Time Frame: Day 1 to Day 176 ]

Secondary Outcome Measures :
  1. Percentage of participants who experience relapse and disability progression [ Time Frame: Throughout the study to Day 176 ]
  2. Lesion volume of new, newly enlarging T2 hyperintense lesions [ Time Frame: Throughout study from Day 0 to Day 113 ]
  3. Number of new, newly-enlarging T2 hyperintense lesions [ Time Frame: Throughout study from Day 0 to Day 113 ]
  4. Total number of new Gadolinium-enhancing T1 lesions [ Time Frame: Throughout study from Day 0 to Day 113 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601885


Locations
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United States, Florida
Compass Research LLC
Orlando, Florida, United States, 32806
United States, Kansas
Rowe Neurology Institute
Lenexa, Kansas, United States, 66214
United States, Maryland
Parexel International
Baltimore, Maryland, United States, 21225
United States, Michigan
MIND
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Tennessee
Tri-State Mountain Neurology
Johnson City, Tennessee, United States, 37604
United States, Texas
Clinical Trial Network
Houston, Texas, United States, 77074
United States, Virginia
Integrated Neurology Services
Alexandria, Virginia, United States, 22310
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02601885    
Other Study ID Numbers: M14-173
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Relapsing-remitting
Secondary progressive
Relapsing forms
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases