A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive 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 progressive Multiple Sclerosis (PMS).

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Participants randomized to receive placebo by intravenous infusion.
Elezanumab 400mg Dose	elezanumab	Participants randomized to receive 400mg of elezanumab by intravenous infusion.
Elezanumab 1800 mg Dose	elezanumab	Participants randomized to receive 1800mg of elezanumab by intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Mean Overall Response Score (ORS)	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 Expanded Disability Status Scale (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 (37): St. Josephs Hospital and Med Center /ID# 202809
🇺🇸
Phoenix, Arizona, 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
Vladimir Royter MD /ID# 202483
🇺🇸
Hanford, California, United States
Stanford MS Center /ID# 202445
🇺🇸
Palo Alto, California, United States
UC Davis Health-Neurological Surgery /ID# 202485
🇺🇸
Sacramento, California, United States
UCSF School of Medicine - Neurology /ID# 203194
🇺🇸
San Francisco, California, United States
University of Colorado School of Medicine, Dept of Neurology /ID# 202807
🇺🇸
Aurora, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 203072
🇺🇸
Fort Collins, Colorado, United States
Rowe Neurology Institute /ID# 202744
🇺🇸
Lenexa, Kansas, United States
Scroll for more (27 remaining)
St. Josephs Hospital and Med Center /ID# 202809
🇺🇸Phoenix, Arizona, United States