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) (ELASCI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury (SCI)
• Intervention / Treatment: Drug: Elezanumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital /ID# 216953
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Recruiting
      • Foothills Medical Centre /ID# 214790
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII - Health Sciences Centre /ID# 215249
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Recruiting
      • The Ottawa Hospital Civic Campus /ID# 215270
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital /ID# 215214
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210
• Israel
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 240917
• Japan
  • Iizuka-shi, Japan, 820-8508
    • Recruiting
    • Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141
  • Aichi
    • Nagoya-shi, Aichi, Japan, 460-0001
      • Recruiting
      • NHO Nagoya Medical Center /ID# 239617
  • Chiba
    • Funabashi-shi, Chiba, Japan, 273-8588
      • Recruiting
      • Funabashi Municipal Medical Center /ID# 225599
  • Tokyo
    • Musashimurayama-shi, Tokyo, Japan, 2080011
      • Recruiting
      • National Hospital Organization Murayama Medical Center /ID# 223492
• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Completed
    • Duplicate_Inha University Hospital /ID# 238890
  • Gyeonggido
    • Suwon, Gyeonggido, Korea, Republic of, 16499
      • Recruiting
      • Ajou University Hospital /ID# 241119
• Spain
  • A Coruna, Spain, 15006
    • Recruiting
    • Hospital Universitario A Coruna - CHUAC /ID# 216384
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron /ID# 217794
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre /ID# 225354
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio /ID# 225692
  • Toledo, Spain, 45071
    • Recruiting
    • Hospital Nacional de Paraplejicos /ID# 225508
  • Valencia, Spain, 46026
    • Completed
    • Hospital Universitario y Politecnico La Fe /ID# 217797
• United States
  • California
    • Sacramento, California, United States, 95817-2307
      • Recruiting
      • UC Davis Health-Neurological Surgery /ID# 224892
  • Georgia
    • Atlanta, Georgia, United States, 30309-1426
      • Recruiting
      • Shepherd Center, Inc /ID# 230370
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Recruiting
      • Northwestern University Feinberg School of Medicine /ID# 218009
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville /ID# 215948
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital /ID# 216342
    • Boston, Massachusetts, United States, 02215-5400
      • Recruiting
      • Beth Israel Deaconess Medical Center /ID# 218149
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Boston, Massachusetts, United States, 02118-2515
      • Recruiting
      • Boston University School of Medicine /ID# 218371
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Boston, Massachusetts, United States, 02111
      • Completed
      • Tufts Medical Center /ID# 225410
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1276
      • Recruiting
      • Regents of the University of Michigan /ID# 215890
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University-School of Medicine /ID# 215325
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack Univ Med Ctr /ID# 215754
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Neptune, New Jersey, United States, 07753-4859
      • Recruiting
      • Jersey Shore University Medical Center /ID# 218162
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Newark, New Jersey, United States, 07103
      • Completed
      • Rutgers New Jersey School of Medicine /ID# 216212
  • North Carolina
    • Durham, North Carolina, United States, 27710-3000
      • Recruiting
      • Duke Cancer Center /ID# 216888
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Medical Research Center /ID# 227371
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • Recruiting
      • University of Pennsylvania /ID# 218662
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital /ID# 215460
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health /ID# 218117
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital /ID# 218302
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Richmond, Virginia, United States, 23219
      • Recruiting
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 217481
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Hospitals /ID# 217344
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Recruiting
      • Medical College of Wisconsin /ID# 215610
      • Contact: Site Coordinator; Phone Number: 844-663-3742

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Participants with comorbid conditions that, in the investigator's opinion, are clinically stable and not expected to meaningfully progress in the following 12 months, may be considered eligible to participate.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elezanumab; Participants will receive elezanumab dose A	Drug: Elezanumab; Solution for infusion; Intravenous (IV); Other Names: ABT-555
Placebo Comparator: Placebo; Participants will receive placebo for elezanumab	Drug: Placebo; Solution for infusion; Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Motor Score (UEMS)	The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.	52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score	The SCIM III self-care score addresses four areas of self-care management: feeding, grooming, bathing, and dressing. It has a total of 4 questions. Scores range from 0-20 where a score of 0 defines total dependence and 20 is indicative of complete independence.	Week 0 through Week 52
Change in Upper Extremity Motor Score (UEMS) From Baseline	The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.	Week 0 through Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2020
• Primary Completion (Estimated): July 18, 2025
• Study Completion (Estimated): April 17, 2026

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: M16-077; 2019-003752-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No