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

Primary Purpose

Multiple Sclerosis (MS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
elezanumab
placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (MS) focused on measuring Relapsing multiple sclerosis, Multiple sclerosis, Elezanumab, ABT-555

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 204618
  • St. Josephs Hospital and Med Center /ID# 204197
  • Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
  • The Research Center of Southern California /ID# 204269
  • Vladimir Royter MD /ID# 204392
  • UC Irvine Health /ID# 205728
  • Stanford MS Center /ID# 204283
  • UC Davis Health-Neurological Surgery /ID# 204188
  • UCSF School of Medicine - Neurology /ID# 204251
  • University of Colorado School of Medicine, Dept of Neurology /ID# 204250
  • Advanced Neurosciences Research, LLC /ID# 204289
  • The University of Chicago Medical Center /ID# 205319
  • Indiana Univ School Medicine /ID# 204891
  • Rowe Neurology Institute /ID# 204391
  • The NeuroMedical Center /ID# 204253
  • Ochsner Medical Center /ID# 204189
  • Duplicate_Parexel International /ID# 204273
  • International Neurorehabilitation Institute /ID# 213332
  • Mass General Hospital /ID# 204279
  • Michigan Institute for Neurological Disorders (MIND) /ID# 204194
  • Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
  • Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
  • Washington University School of Medicine /ID# 204388
  • The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
  • Cleveland Clinic Lou Ruvo Cent /ID# 204745
  • Oklahoma Med Res. Foundation /ID# 204389
  • Providence Neurological Specialties - West /ID# 204248
  • Thomas Jefferson University /ID# 204281
  • Advanced Neurosciences Institute /ID# 204557
  • KCA Neurology - Franklin /ID# 204208
  • Tri-State Mountain Neurology /ID# 204252
  • Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
  • UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
  • Dr. Bhupesh Dihenia, MD, PA /ID# 207839
  • Central Texas Neurology Consul /ID# 204268
  • Integrated Neurology Services /ID# 204261
  • Evergreen Neuroscience Institute /ID# 204203
  • Virginia Mason - Seattle Orthapedics /ID# 205440
  • Swedish MS Center /ID# 204198
  • University of Washington Medicine MS Center /ID# 205852
  • West Virginia Univ School Med /ID# 204292
  • Froedtert Memorial Lutheran Hospital /ID# 204202
  • University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
  • Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
  • The Ottawa Hospital /ID# 204842
  • Unity Health Toronto - St. Michael's Hospital /ID# 206214
  • Recherche Sepmus Inc. /ID# 212851
  • Crchum /Id# 204844
  • Montreal Neurological Institut /ID# 204843

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Elezanumab Dose 1

Elezanumab Dose 2

Arm Description

Participants randomized to receive double-blind placebo by intravenous infusion.

Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.

Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
November 6, 2018
Last Updated
December 1, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03737851
Brief Title
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
September 9, 2021 (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
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)
Keywords
Relapsing multiple sclerosis, Multiple sclerosis, Elezanumab, ABT-555

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive double-blind placebo by intravenous infusion.
Arm Title
Elezanumab Dose 1
Arm Type
Experimental
Arm Description
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
Arm Title
Elezanumab Dose 2
Arm Type
Experimental
Arm Description
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
elezanumab
Other Intervention Name(s)
ABT-555
Intervention Description
solution for infusion
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
solution for infusion
Primary Outcome Measure Information:
Title
Mean Overall Response Score (ORS) at Week 52
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Disability Improvement Response Rate
Description
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).
Time Frame
Week 52
Title
Overall Response Score (ORS)
Description
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).
Time Frame
Up to Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 204618
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
St. Josephs Hospital and Med Center /ID# 204197
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
City
Berkeley
State/Province
California
ZIP/Postal Code
94705-2017
Country
United States
Facility Name
The Research Center of Southern California /ID# 204269
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011-4213
Country
United States
Facility Name
Vladimir Royter MD /ID# 204392
City
Hanford
State/Province
California
ZIP/Postal Code
93230-5787
Country
United States
Facility Name
UC Irvine Health /ID# 205728
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Stanford MS Center /ID# 204283
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1416
Country
United States
Facility Name
UC Davis Health-Neurological Surgery /ID# 204188
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2307
Country
United States
Facility Name
UCSF School of Medicine - Neurology /ID# 204251
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0003
Country
United States
Facility Name
University of Colorado School of Medicine, Dept of Neurology /ID# 204250
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2527
Country
United States
Facility Name
Advanced Neurosciences Research, LLC /ID# 204289
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 205319
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Indiana Univ School Medicine /ID# 204891
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Rowe Neurology Institute /ID# 204391
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
The NeuroMedical Center /ID# 204253
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Ochsner Medical Center /ID# 204189
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Facility Name
Duplicate_Parexel International /ID# 204273
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
International Neurorehabilitation Institute /ID# 213332
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093-6016
Country
United States
Facility Name
Mass General Hospital /ID# 204279
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-4724
Country
United States
Facility Name
Michigan Institute for Neurological Disorders (MIND) /ID# 204194
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867-2116
Country
United States
Facility Name
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318-4551
Country
United States
Facility Name
Washington University School of Medicine /ID# 204388
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131-2322
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Cent /ID# 204745
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-0100
Country
United States
Facility Name
Oklahoma Med Res. Foundation /ID# 204389
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Neurological Specialties - West /ID# 204248
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6646
Country
United States
Facility Name
Thomas Jefferson University /ID# 204281
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Advanced Neurosciences Institute /ID# 204557
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
KCA Neurology - Franklin /ID# 204208
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067-5914
Country
United States
Facility Name
Tri-State Mountain Neurology /ID# 204252
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243-1188
Country
United States
Facility Name
UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1501
Country
United States
Facility Name
Dr. Bhupesh Dihenia, MD, PA /ID# 207839
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 204268
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integrated Neurology Services /ID# 204261
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States
Facility Name
Evergreen Neuroscience Institute /ID# 204203
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3029
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 205440
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish MS Center /ID# 204198
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5698
Country
United States
Facility Name
University of Washington Medicine MS Center /ID# 205852
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133-8400
Country
United States
Facility Name
West Virginia Univ School Med /ID# 204292
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital /ID# 204202
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital /ID# 204842
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Unity Health Toronto - St. Michael's Hospital /ID# 206214
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Recherche Sepmus Inc. /ID# 212851
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Crchum /Id# 204844
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal Neurological Institut /ID# 204843
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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