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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: ABT-555; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research LLC
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Rowe Neurology Institute
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • PAREXEL International
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • MIND
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Univ Med Ctr
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Tri-State Mountain Neurology
  • Texas
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Integrated Neurology Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2; Participants will receive multiple doses of ABT-555 or placebo	Drug: ABT-555; Intravenous Infusion; Other Names: Elezanumab; Other: Placebo; Intravenous Infusion
Experimental: Group 3; Participants will receive multiple doses of ABT-555 or placebo	Drug: ABT-555; Intravenous Infusion; Other Names: Elezanumab; Other: Placebo; Intravenous Infusion
Experimental: Group 1; Participants will receive multiple doses of ABT-555 or placebo	Drug: ABT-555; Intravenous Infusion; Other Names: Elezanumab; Other: Placebo; Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Relapsing forms; Secondary progressive; Relapsing-remitting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: M14-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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