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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 208
• 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# 204841
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 204842
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto - St. Michael's Hospital /ID# 206214
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus Inc. /ID# 212851
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institut /ID# 204843
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 204618
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Josephs Hospital and Med Center /ID# 204197
  • California
    • Berkeley, California, United States, 94705-2017
      • Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
    • Carlsbad, California, United States, 92011-4213
      • The Research Center of Southern California /ID# 204269
    • Hanford, California, United States, 93230-5787
      • Vladimir Royter MD /ID# 204392
    • Irvine, California, United States, 92697
      • UC Irvine Health /ID# 205728
    • Palo Alto, California, United States, 94304-1416
      • Stanford MS Center /ID# 204283
    • Sacramento, California, United States, 95817-2307
      • UC Davis Health-Neurological Surgery /ID# 204188
    • San Francisco, California, United States, 94143-0003
      • UCSF School of Medicine - Neurology /ID# 204251
  • Colorado
    • Aurora, Colorado, United States, 80045-2527
      • University of Colorado School of Medicine /ID# 204250
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, LLC /ID# 204289
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 205319
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ School Medicine /ID# 204891
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Rowe Neurology Institute /ID# 204391
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70810
      • The NeuroMedical Center /ID# 204253
    • New Orleans, Louisiana, United States, 70121-2429
      • Ochsner Medical Center /ID# 204189
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Duplicate_Parexel International /ID# 204273
    • Lutherville, Maryland, United States, 21093-6016
      • International Neurorehabilitation Institute /ID# 213332
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Pediatric Endocrine Associates /ID# 204279
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute for Neurological Disorders (MIND) /ID# 204194
    • Owosso, Michigan, United States, 48867-2116
      • Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
  • Minnesota
    • Chaska, Minnesota, United States, 55318-4551
      • Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
  • Missouri
    • Saint Louis, Missouri, United States, 63131-2322
      • The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 204388
  • Nevada
    • Las Vegas, Nevada, United States, 89106-0100
      • Cleveland Clinic Lou Ruvo Cent /ID# 204745
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Med Res. Foundation /ID# 204389
  • Oregon
    • Portland, Oregon, United States, 97225-6646
      • Providence Neurological Specialties - West /ID# 204248
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University /ID# 204281
  • Tennessee
    • Franklin, Tennessee, United States, 37064
      • Advanced Neurosciences Institute /ID# 204557
    • Franklin, Tennessee, United States, 37067-5914
      • KCA Neurology - Franklin /ID# 204208
    • Johnson City, Tennessee, United States, 37604
      • Tri-State Mountain Neurology /ID# 204252
  • Texas
    • Dallas, Texas, United States, 75243-1188
      • Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
    • Houston, Texas, United States, 77030-1501
      • UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
    • Lubbock, Texas, United States, 79410
      • Dr. Bhupesh Dihenia, MD, PA /ID# 207839
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consul /ID# 204268
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Integrated Neurology Services, PLLC /ID# 204261
  • Washington
    • Kirkland, Washington, United States, 98034-3029
      • Evergreen Neuroscience Institute /ID# 204203
    • Seattle, Washington, United States, 98122-5698
      • Swedish MS Center /ID# 204198
    • Seattle, Washington, United States, 98133-8400
      • University of Washington Medicine MS Center /ID# 205852
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center /ID# 205440
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia Univ School Med /ID# 204292
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Froedtert Memorial Lutheran Hospital /ID# 204202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months.
• Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS).
• Participant has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

Exclusion Criteria:

- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.

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 double-blind placebo by intravenous infusion.	Drug: placebo; solution for infusion
Experimental: Elezanumab Dose 1; Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.	Drug: elezanumab; solution for infusion; Other Names: ABT-555
Experimental: Elezanumab Dose 2; Participants randomized to receive double-blind elezanumab Dose 2 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) at Week 52	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 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). 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
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 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): September 9, 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 (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Relapsing multiple sclerosis; Elezanumab; ABT-555
• 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: M18-918

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