A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis (MS)
• Intervention / Treatment: Drug: placebo; Drug: elezanumab

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 203058
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto - St. Michael's Hospital /ID# 206213
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus Inc. /ID# 212852
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institut /ID# 203868
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Josephs Hospital and Med Center /ID# 202809
  • California
    • Berkeley, California, United States, 94705-2017
      • Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
    • Carlsbad, California, United States, 92011-4213
      • The Research Center of Southern California /ID# 202802
    • Hanford, California, United States, 93230-5787
      • Vladimir Royter MD /ID# 202483
    • Palo Alto, California, United States, 94304-1416
      • Stanford MS Center /ID# 202445
    • Sacramento, California, United States, 95817-2307
      • UC Davis Health-Neurological Surgery /ID# 202485
    • San Francisco, California, United States, 94143-0003
      • UCSF School of Medicine - Neurology /ID# 203194
  • Colorado
    • Aurora, Colorado, United States, 80045-2527
      • University of Colorado School of Medicine, Dept of Neurology /ID# 202807
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, LLC /ID# 203072
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Rowe Neurology Institute /ID# 202744
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Duplicate_Parexel International /ID# 202747
    • Lutherville, Maryland, United States, 21093-6016
      • International Neurorehabilitation Institute /ID# 213333
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute for Neurological Disorders (MIND) /ID# 202470
    • Owosso, Michigan, United States, 48867-2116
      • Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
  • Minnesota
    • Chaska, Minnesota, United States, 55318-4551
      • Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
  • Missouri
    • Saint Louis, Missouri, United States, 63131-2322
      • The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 202899
  • Nevada
    • Las Vegas, Nevada, United States, 89106-0100
      • Cleveland Clinic Lou Ruvo Cent /ID# 204744
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Med Res. Foundation /ID# 203442
  • Oregon
    • Portland, Oregon, United States, 97225-6646
      • Providence Neurological Specialties - West /ID# 203193
  • Tennessee
    • Franklin, Tennessee, United States, 37064
      • Advanced Neurosciences Institute /ID# 204555
    • Franklin, Tennessee, United States, 37067-5914
      • KCA Neurology - Franklin /ID# 202912
  • Texas
    • Dallas, Texas, United States, 75243-1188
      • Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consul /ID# 203108
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Integrated Neurology Services /ID# 202743
  • Washington
    • Kirkland, Washington, United States, 98034-3029
      • Evergreen Neuroscience Institute /ID# 204205
    • Seattle, Washington, United States, 98122-5698
      • Swedish MS Center /ID# 202904
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center /ID# 205439
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia Univ School Med /ID# 202849
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Froedtert Memorial Lutheran Hospital /ID# 202618

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months.
• Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

Exclusion Criteria:

• Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification.
• Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.

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
Placebo Comparator: Placebo; Participants randomized to receive placebo by intravenous infusion.	Drug: placebo; solution for infusion
Experimental: Elezanumab 400mg Dose; Participants randomized to receive 400mg of elezanumab by intravenous infusion.	Drug: elezanumab; solution for infusion; Other Names: ABT-555
Experimental: Elezanumab 1800 mg Dose; Participants randomized to receive 1800mg of elezanumab by intravenous infusion.	Drug: elezanumab; solution for infusion; Other Names: ABT-555

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Overall Response Score (ORS)	The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability Improvement Response Rate	Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).	Week 52
Overall Response Score (ORS)	The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).	Week 12
Overall Response Score (ORS)	The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.	Week 24
Overall Response Score (ORS)	The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.	Week 36

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Elezanumab; ABT-555; Progressive multiple sclerosis
• 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: M14-397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

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