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

Multiple Sclerosis (MS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737812
• Other study ID #: M14-397
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2019
• Est. completion date: August 30, 2021

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 30, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

Intervention

Drug:
• elezanumab
solution for infusion
• placebo
solution for infusion

Locations

Country	Name	City	State
Canada	Recherche Sepmus Inc. /ID# 212852	Greenfield Park	Quebec
Canada	Duplicate_London Health Sciences Centre - University Hospital /ID# 203538	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869	Montreal	Quebec
Canada	Montreal Neurological Institut /ID# 203868	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 203058	Ottawa	Ontario
Canada	Unity Health Toronto - St. Michael's Hospital /ID# 206213	Toronto	Ontario
Canada	University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536	Vancouver	British Columbia
United States	Integrated Neurology Services /ID# 202743	Alexandria	Virginia
United States	University of Colorado School of Medicine, Dept of Neurology /ID# 202807	Aurora	Colorado
United States	Duplicate_Parexel International /ID# 202747	Baltimore	Maryland
United States	Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448	Berkeley	California
United States	The Research Center of Southern California /ID# 202802	Carlsbad	California
United States	Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384	Chaska	Minnesota
United States	Neurology Consultants of Dallas - LBJ Fwy /ID# 203102	Dallas	Texas
United States	Michigan Institute for Neurological Disorders (MIND) /ID# 202470	Farmington Hills	Michigan
United States	Advanced Neurosciences Research, LLC /ID# 203072	Fort Collins	Colorado
United States	Advanced Neurosciences Institute /ID# 204555	Franklin	Tennessee
United States	KCA Neurology - Franklin /ID# 202912	Franklin	Tennessee
United States	Vladimir Royter MD /ID# 202483	Hanford	California
United States	Evergreen Neuroscience Institute /ID# 204205	Kirkland	Washington
United States	Cleveland Clinic Lou Ruvo Cent /ID# 204744	Las Vegas	Nevada
United States	Rowe Neurology Institute /ID# 202744	Lenexa	Kansas
United States	International Neurorehabilitation Institute /ID# 213333	Lutherville	Maryland
United States	Froedtert Memorial Lutheran Hospital /ID# 202618	Milwaukee	Wisconsin
United States	West Virginia Univ School Med /ID# 202849	Morgantown	West Virginia
United States	Oklahoma Med Res. Foundation /ID# 203442	Oklahoma City	Oklahoma
United States	Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327	Owosso	Michigan
United States	Stanford MS Center /ID# 202445	Palo Alto	California
United States	St. Josephs Hospital and Med Center /ID# 202809	Phoenix	Arizona
United States	Providence Neurological Specialties - West /ID# 203193	Portland	Oregon
United States	Central Texas Neurology Consul /ID# 203108	Round Rock	Texas
United States	UC Davis Health-Neurological Surgery /ID# 202485	Sacramento	California
United States	The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432	Saint Louis	Missouri
United States	Washington University-School of Medicine /ID# 202899	Saint Louis	Missouri
United States	UCSF School of Medicine - Neurology /ID# 203194	San Francisco	California
United States	Swedish MS Center /ID# 202904	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 205439	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)	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 Expanded Disability Status Scale (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).	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