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)

Spinal Cord Injury (SCI) Clinical Trial

— ELASCI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04295538
• Other study ID #: M16-077
• Secondary ID: 2019-003752-36
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 6, 2020
• Est. completion date: April 17, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: April 17, 2026
• Est. primary completion date: July 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury (SCI)
• Wounds and Injuries

Intervention

Drug:
• Elezanumab
Solution for infusion; Intravenous (IV)
• Placebo
Solution for infusion; Intravenous (IV)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 216953	Adelaide	South Australia
Canada	Foothills Medical Centre /ID# 214790	Calgary	Alberta
Canada	QEII - Health Sciences Centre /ID# 215249	Halifax	Nova Scotia
Canada	CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210	Montreal	Quebec
Canada	The Ottawa Hospital Civic Campus /ID# 215270	Ottawa	Ontario
Canada	Toronto Western Hospital /ID# 215214	Toronto	Ontario
Israel	The Chaim Sheba Medical Center /ID# 240917	Ramat Gan	Tel-Aviv
Japan	Funabashi Municipal Medical Center /ID# 225599	Funabashi-shi	Chiba
Japan	Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141	Iizuka-shi
Japan	National Hospital Organization Murayama Medical Center /ID# 223492	Musashimurayama-shi	Tokyo
Japan	NHO Nagoya Medical Center /ID# 239617	Nagoya-shi	Aichi
Korea, Republic of	Duplicate_Inha University Hospital /ID# 238890	??	Incheon Gwang Yeogsi
Korea, Republic of	Ajou University Hospital /ID# 241119	Suwon-si	Gyeonggido
Spain	Complejo Hospitalario Universitario A Coruña /ID# 216384	A Coruña	A Coruna
Spain	Hospital Universitario Vall d'Hebron /ID# 217794	Barcelona
Spain	Hospital Universitario 12 de Octubre /ID# 225354	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 225692	Sevilla
Spain	Hospital Nacional de Paraplejicos /ID# 225508	Toledo
Spain	Hospital Universitario y Politecnico La Fe /ID# 217797	Valencia
United States	Regents of the University of Michigan /ID# 215890	Ann Arbor	Michigan
United States	Shepherd Center, Inc /ID# 230370	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center /ID# 218149	Boston	Massachusetts
United States	Boston University School of Medicine /ID# 218371	Boston	Massachusetts
United States	Brigham & Women's Hospital /ID# 216342	Boston	Massachusetts
United States	Tufts Medical Center /ID# 225410	Boston	Massachusetts
United States	University of Virginia Health /ID# 218117	Charlottesville	Virginia
United States	Northwestern University Feinberg School of Medicine /ID# 218009	Chicago	Illinois
United States	Duke Cancer Center /ID# 216888	Durham	North Carolina
United States	Hackensack Univ Med Ctr /ID# 215754	Hackensack	New Jersey
United States	University of Louisville Hospital /ID# 215948	Louisville	Kentucky
United States	Wisconsin Medical Center /ID# 215610	Milwaukee	Wisconsin
United States	West Virginia University Hospitals /ID# 217344	Morgantown	West Virginia
United States	Jersey Shore University Medical Center /ID# 218162	Neptune	New Jersey
United States	Rutgers New Jersey School of Medicine /ID# 216212	Newark	New Jersey
United States	Sentara Norfolk General Hospital /ID# 218302	Norfolk	Virginia
United States	Thomas Jefferson University Hospital /ID# 215460	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 218662	Philadelphia	Pennsylvania
United States	Oregon Medical Research Center /ID# 227371	Portland	Oregon
United States	Virginia Commonwealth University Medical Center Main Hospital /ID# 217481	Richmond	Virginia
United States	University of California Davis Health /ID# 224892	Sacramento	California
United States	Washington University-School of Medicine /ID# 215325	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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