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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03737851
Other study ID # M18-918
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 11, 2018
Est. completion date September 9, 2021

Study information

Verified date December 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date September 9, 2021
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
elezanumab
solution for infusion
placebo
solution for infusion

Locations

Country Name City State
Canada Recherche Sepmus Inc. /ID# 212851 Greenfield Park Quebec
Canada Duplicate_London Health Sciences Centre - University Hospital /ID# 204848 London Ontario
Canada Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844 Montreal Quebec
Canada Montreal Neurological Institut /ID# 204843 Montreal Quebec
Canada Ottawa Hospital Research Institute /ID# 204842 Ottawa Ontario
Canada Unity Health Toronto - St. Michael's Hospital /ID# 206214 Toronto Ontario
Canada University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841 Vancouver British Columbia
United States Integrated Neurology Services, PLLC /ID# 204261 Alexandria Virginia
United States University of Colorado School of Medicine /ID# 204250 Aurora Colorado
United States Duplicate_Parexel International /ID# 204273 Baltimore Maryland
United States The NeuroMedical Center /ID# 204253 Baton Rouge Louisiana
United States Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249 Berkeley California
United States University of Alabama at Birmingham - Main /ID# 204618 Birmingham Alabama
United States Pediatric Endocrine Associates /ID# 204279 Boston Massachusetts
United States The Research Center of Southern California /ID# 204269 Carlsbad California
United States Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383 Chaska Minnesota
United States The University of Chicago Medical Center /ID# 205319 Chicago Illinois
United States Neurology Consultants of Dallas - LBJ Fwy /ID# 204398 Dallas Texas
United States Michigan Institute for Neurological Disorders (MIND) /ID# 204194 Farmington Hills Michigan
United States Advanced Neurosciences Research, LLC /ID# 204289 Fort Collins Colorado
United States Advanced Neurosciences Institute /ID# 204557 Franklin Tennessee
United States KCA Neurology - Franklin /ID# 204208 Franklin Tennessee
United States Vladimir Royter MD /ID# 204392 Hanford California
United States UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418 Houston Texas
United States Indiana Univ School Medicine /ID# 204891 Indianapolis Indiana
United States UC Irvine Health /ID# 205728 Irvine California
United States Tri-State Mountain Neurology /ID# 204252 Johnson City Tennessee
United States Evergreen Neuroscience Institute /ID# 204203 Kirkland Washington
United States Cleveland Clinic Lou Ruvo Cent /ID# 204745 Las Vegas Nevada
United States Rowe Neurology Institute /ID# 204391 Lenexa Kansas
United States Dr. Bhupesh Dihenia, MD, PA /ID# 207839 Lubbock Texas
United States International Neurorehabilitation Institute /ID# 213332 Lutherville Maryland
United States Froedtert Memorial Lutheran Hospital /ID# 204202 Milwaukee Wisconsin
United States West Virginia Univ School Med /ID# 204292 Morgantown West Virginia
United States Ochsner Medical Center /ID# 204189 New Orleans Louisiana
United States Oklahoma Med Res. Foundation /ID# 204389 Oklahoma City Oklahoma
United States Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328 Owosso Michigan
United States Stanford MS Center /ID# 204283 Palo Alto California
United States Thomas Jefferson University /ID# 204281 Philadelphia Pennsylvania
United States St. Josephs Hospital and Med Center /ID# 204197 Phoenix Arizona
United States Providence Neurological Specialties - West /ID# 204248 Portland Oregon
United States Central Texas Neurology Consul /ID# 204268 Round Rock Texas
United States UC Davis Health-Neurological Surgery /ID# 204188 Sacramento California
United States The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433 Saint Louis Missouri
United States Washington University-School of Medicine /ID# 204388 Saint Louis Missouri
United States UCSF School of Medicine - Neurology /ID# 204251 San Francisco California
United States Swedish MS Center /ID# 204198 Seattle Washington
United States University of Washington Medicine MS Center /ID# 205852 Seattle Washington
United States Virginia Mason Medical Center /ID# 205440 Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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