Clinical trial NCT04295538: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Spinal Cord Injury (SCI)
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 18-75 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Upper Extremity Motor Score (UEMS)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score
timeFrame: Week 0 through Week 52
measure: Change in Upper Extremity Motor Score (UEMS) From Baseline
timeFrame: Week 0 through Week 52
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health /ID# 224892
state: California
city: Atlanta
country: United States
facility: Shepherd Center, Inc /ID# 230370
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 218009
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 215948
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center /ID# 225410
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital /ID# 216342
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine /ID# 218371
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 218149
state: Massachusetts
city: Ann Arbor
country: United States
facility: Regents of the University of Michigan /ID# 215890
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 215325
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 215754
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 218162
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey School of Medicine /ID# 216212
state: New Jersey
city: Durham
country: United States
facility: Duke Cancer Center /ID# 216888
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 227371
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 218662
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 215460
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Health /ID# 218117
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital /ID# 218302
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 217481
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 217344
state: West Virginia
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 215610
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 216953
state: South Australia
city: Calgary
country: Canada
facility: Foothills Medical Centre /ID# 214790
state: Alberta
city: Halifax
country: Canada
facility: QEII - Health Sciences Centre /ID# 215249
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic Campus /ID# 215270
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 215214
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210
state: Quebec
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 240917
state: Tel-Aviv
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 239617
state: Aichi
city: Funabashi-shi
country: Japan
facility: Funabashi Municipal Medical Center /ID# 225599
state: Chiba
city: Musashimurayama-shi
country: Japan
facility: National Hospital Organization Murayama Medical Center /ID# 223492
state: Tokyo
city: Iizuka-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 241119
state: Gyeonggido
city: 중구
country: Korea, Republic of
facility: Duplicate_Inha University Hospital /ID# 238890
state: Incheon Gwang Yeogsi
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 216384
state: A Coruna
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 217794
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 225354
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 225692
city: Toledo
country: Spain
facility: Hospital Nacional de Paraplejicos /ID# 225508
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 217797
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: