Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

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 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

Keywords

Spinal Cord Injury (SCI) Cervical Spinal Cord Injury Cervical SCI Elezanumab ABT-555 Upper Extremity Motor Score (UEMS) Acute Traumatic Cervical Spinal Cord Injury Spinal Cord Injuries Wounds and Injuries

Eligibility

You can join if…

Open to people ages 18-75

  • Acute traumatic cervical spinal cord injury (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.

You CAN'T join if...

  • 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 International Standards for Neurological Classification of Spinal Cord Injury (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.

Locations

  • UC Davis Health-Neurological Surgery /ID# 224892 not yet accepting patients
    Sacramento California 95817-2307 United States
  • Oregon Health and Science University /ID# 227371 not yet accepting patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04295538
Phase
Phase 2
Study Type
Interventional
Last Updated