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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737851
• Other study ID #: M18-918
• Status: Completed
• Phase: Phase 2
• 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
• 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.

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# 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