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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
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)

Recruiting Locations

TIRR Memorial Hermann UT Health
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Mitsubishi Tanabe Pharma America Inc.

Study Contact

Clinical Trials Information Desk, to prevent miscommunication,
please email:
information@mt-pharma-us.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.