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

Purpose

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.

Condition

  • Spinal Cord Injury

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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)

More Details

Status
Completed
Sponsor
Mitsubishi Tanabe Pharma America Inc.

Study Contact