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

NCT04683848 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: MT-3921-A01jRCT2031210320
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 23

Brief Summary

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Spinal Cord Independence Measurement (SCIM) III score

  Baseline and at Day 180

• Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score

  Baseline and at Day 180

• Change in Spinal Cord Ability Ruler (SCAR)

  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

Study Arms (2)

MT-3921

EXPERIMENTAL

Intravenous (IV)

Biological: MT-3921

Placebo

PLACEBO COMPARATOR

Intravenous (IV)

Biological: Placebo

Interventions

MT-3921 BIOLOGICAL

Solution for infusion; Intravenous (IV)

Also known as: Unasnemab

MT-3921

Placebo BIOLOGICAL

Solution for infusion; Intravenous (IV)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (23)

University of California Irvine

Orange, California, 92868, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Oregon Health and Science University - Center for Health & Healing

Portland, Oregon, 97239, United States

Location

Brooke Army Medical Center in San Antonio

Houston, Texas, 78234, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

NSHA-Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H3A7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER

Izuka-shi, Fukuoka, 820-8508, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Hokkaido Spinal Cord Injury Center

Bibai-shi, Hokkaido, 072-0015, Japan

Location

Japanese Red Cross Kobe Hospital

Kobe, Hyōgo, 651-0073, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, Kumamoto, 860-0008, Japan

Location

Murayama Medical Center

Musashimurayama-shi, Tokyo, 208-0011, Japan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: August 27, 2021
• Primary Completion: December 24, 2024
• Study Completion: April 9, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

JP (6); US (15); CA (2)