Back to resultsA Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Primary Purpose
Multiple Sclerosis (MS)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
elezanumab
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis (MS) focused on measuring Progressive multiple sclerosis, Elezanumab, ABT-555
Eligibility Criteria
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.
Sites / Locations
- St. Josephs Hospital and Med Center /ID# 202809
- Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
- The Research Center of Southern California /ID# 202802
- Vladimir Royter MD /ID# 202483
- Stanford MS Center /ID# 202445
- UC Davis Health-Neurological Surgery /ID# 202485
- UCSF School of Medicine - Neurology /ID# 203194
- University of Colorado School of Medicine, Dept of Neurology /ID# 202807
- Advanced Neurosciences Research, LLC /ID# 203072
- Rowe Neurology Institute /ID# 202744
- Duplicate_Parexel International /ID# 202747
- International Neurorehabilitation Institute /ID# 213333
- Michigan Institute for Neurological Disorders (MIND) /ID# 202470
- Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
- Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
- Washington University School of Medicine /ID# 202899
- The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
- Cleveland Clinic Lou Ruvo Cent /ID# 204744
- Oklahoma Med Res. Foundation /ID# 203442
- Providence Neurological Specialties - West /ID# 203193
- Advanced Neurosciences Institute /ID# 204555
- KCA Neurology - Franklin /ID# 202912
- Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
- Central Texas Neurology Consul /ID# 203108
- Integrated Neurology Services /ID# 202743
- Evergreen Neuroscience Institute /ID# 204205
- Virginia Mason - Seattle Orthapedics /ID# 205439
- Swedish MS Center /ID# 202904
- West Virginia Univ School Med /ID# 202849
- Froedtert Memorial Lutheran Hospital /ID# 202618
- University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
- Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
- The Ottawa Hospital /ID# 203058
- Unity Health Toronto - St. Michael's Hospital /ID# 206213
- Recherche Sepmus Inc. /ID# 212852
- Crchum /Id# 203869
- Montreal Neurological Institut /ID# 203868
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)
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
1. Study Identification
Unique Protocol Identification Number
NCT03737812
Brief Title
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive 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 Progressive Forms of Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
August 30, 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 progressive Multiple Sclerosis (PMS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)
Keywords
Progressive 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
123 (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)
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
St. Josephs Hospital and Med Center /ID# 202809
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# 202448
City
Berkeley
State/Province
California
ZIP/Postal Code
94705-2017
Country
United States
Facility Name
The Research Center of Southern California /ID# 202802
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011-4213
Country
United States
Facility Name
Vladimir Royter MD /ID# 202483
City
Hanford
State/Province
California
ZIP/Postal Code
93230-5787
Country
United States
Facility Name
Stanford MS Center /ID# 202445
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1416
Country
United States
Facility Name
UC Davis Health-Neurological Surgery /ID# 202485
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2307
Country
United States
Facility Name
UCSF School of Medicine - Neurology /ID# 203194
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# 202807
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2527
Country
United States
Facility Name
Advanced Neurosciences Research, LLC /ID# 203072
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Rowe Neurology Institute /ID# 202744
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Duplicate_Parexel International /ID# 202747
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
International Neurorehabilitation Institute /ID# 213333
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093-6016
Country
United States
Facility Name
Michigan Institute for Neurological Disorders (MIND) /ID# 202470
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867-2116
Country
United States
Facility Name
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318-4551
Country
United States
Facility Name
Washington University School of Medicine /ID# 202899
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# 205432
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131-2322
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Cent /ID# 204744
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-0100
Country
United States
Facility Name
Oklahoma Med Res. Foundation /ID# 203442
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Neurological Specialties - West /ID# 203193
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6646
Country
United States
Facility Name
Advanced Neurosciences Institute /ID# 204555
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
KCA Neurology - Franklin /ID# 202912
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067-5914
Country
United States
Facility Name
Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243-1188
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 203108
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integrated Neurology Services /ID# 202743
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States
Facility Name
Evergreen Neuroscience Institute /ID# 204205
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3029
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 205439
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish MS Center /ID# 202904
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5698
Country
United States
Facility Name
West Virginia Univ School Med /ID# 202849
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital /ID# 202618
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# 203536
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital /ID# 203058
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Unity Health Toronto - St. Michael's Hospital /ID# 206213
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Recherche Sepmus Inc. /ID# 212852
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Crchum /Id# 203869
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal Neurological Institut /ID# 203868
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
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
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