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

Phase 2

Completed

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

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Elezanumab Dose 2	elezanumab	Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
Placebo	placebo	Participants randomized to receive double-blind placebo by intravenous infusion.
Elezanumab Dose 1	elezanumab	Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Mean Overall Response Score (ORS) at Week 52	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.

Secondary Outcome Measures

Name	Time	Method
Disability Improvement Response Rate	Week 52	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)	Week 36	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.

Locations (49): University of Alabama at Birmingham - Main /ID# 204618
🇺🇸
Birmingham, Alabama, United States
St. Josephs Hospital and Med Center /ID# 204197
🇺🇸
Phoenix, Arizona, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
🇺🇸
Berkeley, California, United States
The Research Center of Southern California /ID# 204269
🇺🇸
Carlsbad, California, United States
Vladimir Royter MD /ID# 204392
🇺🇸
Hanford, California, United States
UC Irvine Health /ID# 205728
🇺🇸
Irvine, California, United States
Stanford MS Center /ID# 204283
🇺🇸
Palo Alto, California, United States
UC Davis Health-Neurological Surgery /ID# 204188
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Sacramento, California, United States
UCSF School of Medicine - Neurology /ID# 204251
🇺🇸
San Francisco, California, United States
University of Colorado School of Medicine /ID# 204250
🇺🇸
Aurora, Colorado, United States
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University of Alabama at Birmingham - Main /ID# 204618
🇺🇸Birmingham, Alabama, United States