Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury.

Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Biological: MT-3921; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • NSHA-Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4E9
      • The Ottawa Hospital
• Japan
  • Fukuoka
    • Izuka-shi, Fukuoka, Japan, 820-8508
      • Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital
  • Hokkaido
    • Bibai-shi, Hokkaido, Japan, 072-0015
      • Hokkaido Spinal Cord Injury Center
  • Hyōgo
    • Kobe, Hyōgo, Japan, 651-0073
      • Japanese Red Cross Kobe Hospital
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-0008
      • National Hospital Organization Kumamoto Medical Center
  • Tokyo
    • Musashimurayama-shi, Tokyo, Japan, 208-0011
      • Murayama Medical Center
• United States
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Saint Louis University Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Rehabilitation
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University - Center for Health & Healing
  • Texas
    • Houston, Texas, United States, 78234
      • Brooke Army Medical Center in San Antonio
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin - Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

• Provide written informed consent prior to beginning any study procedures

• Cervical spinal cord injury that meet all of the following criteria:

  • Classified as AIS A, AIS B or AIS C
  • ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)
  • UEMS ≤28 at Screening
• Body mass index (BMI) <40

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

• Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
• Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
• Penetrating spinal cord injuries
• Complete transection of the spinal cord
• Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
• History of anaphylaxis or clinically significant allergic reactions to any medication
• History or presence of malignancy within the last 3 years prior to screening
• Subjects with current SARS-CoV-2 infection (COVID-19)
• Subjects with hereditary fructose intolerance
• Psychoactive substance use disorder
• Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
• Female subjects who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-3921; Intravenous (IV)	Biological: MT-3921; Solution for infusion; Intravenous (IV); Other Names: Unasnemab
Placebo Comparator: Placebo; Intravenous (IV)	Biological: Placebo; Solution for infusion; Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper Extremity Motor Score (UEMS)	The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that focuses selectively on function of 5 key muscles in the upper limbs. UEMS ranges from 0 to 50 points, where a higher score indicates a better movement.	Baseline and at Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spinal Cord Independence Measurement (SCIM) III score	The SCIM III is a comprehensive rating scale that measures the ability of patients with SCI to perform everyday tasks according to their value for the patient. The SCIM III is grouped into four subscales: Self-Care, Respiration and Sphincter Management, Mobility in Room and Toilet, and Mobility Indoors and Outdoors. The total SCIM III score ranges from 0 to 100 points, with 0 point being requiring total assistance and 100 points being completely independent.	Baseline and at Day 180
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score	The GRASSP measures sensorimotor and prehension function through three domains (Strength, Sensation and Prehension) which are important in describing arm and hand function. The total GRASSP score ranges from 0 to 116 points, where a higher score indicates a better outcome.	Baseline and at Day 180
Change in Spinal Cord Ability Ruler (SCAR)	The SCAR measures voluntary task specific physical actions contributing to independence in ability of daily living. The SCAR uses select items from the upper limb motor assessments of the ISNCSCI and the SCIM III.	Baseline and at Day 180
Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)		Baseline and at Day 180

Collaborators and Investigators

• Sponsor: Tanabe Pharma America, Inc.
• Investigators: Study Director: Head of Medical Science, Tanabe Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: MT-3921-A01; jRCT2031210320 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No