ELASCI

Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)

Brief summary

Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-70 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 36 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Recruiting
Conditions:
Spinal Cord Injury (SCI)
Enrollment:
54 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-077
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 70 Years.

Inclusion Criteria:

- Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 with
no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the
investigator's opinion, would significantly limit recovery.

- Maximum screening UEMS of 32.

- American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.

- Able to initiate study drug administration within 24 hours of injury.

Exclusion Criteria:

- Evidence of complete spinal cord transection.

- Significant concomitant head injury with a clinically significant abnormality on a
head computed tomography (CT).

- One or more upper extremity muscle groups untestable (e.g., immobilized or restricted
by a cast) during the screening ISNCSCI examination.

- Known history prior to randomization of clinically significant medical or surgical
conditions (other than current acute SCI) or any other reason, including any physical,
psychological, or psychiatric condition that in the opinion of the Investigator would
compromise the safety or interfere with the participant's participation in this study,
or would make the participant an unsuitable candidate to receive study drug, or would
put the participant at risk by participating in the study, including history of or
abnormal screening lab or imaging results that, in the opinion of the investigator,
are indicative of any irreparable cardiac, endocrinologic, hematologic, hepatic,
immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal,
dermatologic, psychiatric, renal, neurologic, and/or other major disease that would
preclude administration of elezanumab.

- Known receipt of any other investigational product within 30 days or 5 half-lives of
the drug (whichever is longer) prior to the first dose of study drug or is currently
enrolled in another clinical study.

- Female who is pregnant, breastfeeding, or considering becoming pregnant during the
study or for within 39 weeks (5 half-lives) after the last dose of study drug.

- The cause of the acute SCI is one of the following: from gunshot or penetrating/stab
wound; non-traumatic SCI, results of seizure, or known attempted suicide.

All the cities where the clinical studies are located

Calgary - T2N 2T9

Halifax - B3H 2Y9

Ottawa - K1Y 4E9

Toronto - M5B 1W8

Toronto - M5T 2S8

Montreal - H4J 1C5

Alberta

Nova Scotia

Quebec