Back to resultsSafety 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)
Primary Purpose
Spinal Cord Injury (SCI)
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elezanumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury (SCI) focused on measuring Spinal Cord Injury (SCI), Cervical Spinal Cord Injury, Cervical SCI, Elezanumab, ABT-555, Upper Extremity Motor Score (UEMS), Acute Traumatic Cervical Spinal Cord Injury
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.
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 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.
Sites / Locations
- UC Davis Health-Neurological Surgery /ID# 224892Recruiting
- Shepherd Center, Inc /ID# 230370Recruiting
- Northwestern University Feinberg School of Medicine /ID# 218009Recruiting
- University of Louisville /ID# 215948Recruiting
- Tufts Medical Center /ID# 225410Recruiting
- Brigham & Women's Hospital /ID# 216342Recruiting
- Boston University School of Medicine /ID# 218371Recruiting
- Beth Israel Deaconess Medical Center /ID# 218149Recruiting
- Regents of the University of Michigan /ID# 215890Recruiting
- Washington University-School of Medicine /ID# 215325Recruiting
- Hackensack Univ Med Ctr /ID# 215754Recruiting
- Jersey Shore University Medical Center /ID# 218162Recruiting
- Rutgers New Jersey School of Medicine /ID# 216212
- Duke Cancer Center /ID# 216888Recruiting
- Oregon Medical Research Center /ID# 227371Recruiting
- University of Pennsylvania /ID# 218662Recruiting
- Thomas Jefferson University Hospital /ID# 215460Recruiting
- University of Virginia Health /ID# 218117Recruiting
- Sentara Norfolk General Hospital /ID# 218302Recruiting
- Virginia Commonwealth University Medical Center Main Hospital /ID# 217481Recruiting
- West Virginia University Hospitals /ID# 217344Recruiting
- Medical College of Wisconsin /ID# 215610Recruiting
- Royal Adelaide Hospital /ID# 216953Recruiting
- University of Calgary - Foothills Medical Centre /ID# 214790Recruiting
- QEII - Health Sciences Centre /ID# 215249Recruiting
- The Ottawa Hospital Civic Campus /ID# 215270Recruiting
- Toronto Western Hospital /ID# 215214Recruiting
- CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210Recruiting
- The Chaim Sheba Medical Center /ID# 240917Recruiting
- NHO Nagoya Medical Center /ID# 239617Recruiting
- Funabashi Municipal Medical Center /ID# 225599Recruiting
- National Hospital Organization Murayama Medical Center /ID# 223492Recruiting
- Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141Recruiting
- Ajou University Hospital /ID# 241119Recruiting
- Inha University Hospital /ID# 238890
- Hospital Universitario A Coruna - CHUAC /ID# 216384Recruiting
- Hospital Universitario Vall d'Hebron /ID# 217794Recruiting
- Hospital Universitario 12 de Octubre /ID# 225354Recruiting
- Hospital Universitario Virgen del Rocio /ID# 225692Recruiting
- Hospital Nacional de Paraplejicos /ID# 225508Recruiting
- Hospital Universitario y Politecnico La Fe /ID# 217797
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Elezanumab
Placebo
Arm Description
Participants will receive elezanumab dose A
Participants will receive placebo for elezanumab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04295538
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2020 (Actual)
Primary Completion Date
July 18, 2025 (Anticipated)
Study Completion Date
April 17, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elezanumab
Arm Type
Experimental
Arm Description
Participants will receive elezanumab dose A
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for elezanumab
Intervention Type
Drug
Intervention Name(s)
Elezanumab
Other Intervention Name(s)
ABT-555
Intervention Description
Solution for infusion; Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion; Intravenous (IV)
Primary Outcome Measure Information:
Title
Upper Extremity Motor Score (UEMS)
Description
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.
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score
Description
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.
Time Frame
Week 0 through Week 52
Title
Change in Upper Extremity Motor Score (UEMS) From Baseline
Description
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.
Time Frame
Week 0 through Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UC Davis Health-Neurological Surgery /ID# 224892
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2307
Country
United States
Individual Site Status
Recruiting
Facility Name
Shepherd Center, Inc /ID# 230370
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-1426
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University Feinberg School of Medicine /ID# 218009
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville /ID# 215948
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Tufts Medical Center /ID# 225410
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham & Women's Hospital /ID# 216342
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston University School of Medicine /ID# 218371
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Beth Israel Deaconess Medical Center /ID# 218149
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Regents of the University of Michigan /ID# 215890
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-1276
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Washington University-School of Medicine /ID# 215325
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Hackensack Univ Med Ctr /ID# 215754
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Jersey Shore University Medical Center /ID# 218162
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753-4859
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Rutgers New Jersey School of Medicine /ID# 216212
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Completed
Facility Name
Duke Cancer Center /ID# 216888
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Oregon Medical Research Center /ID# 227371
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania /ID# 218662
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University Hospital /ID# 215460
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Virginia Health /ID# 218117
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Sentara Norfolk General Hospital /ID# 218302
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Virginia Commonwealth University Medical Center Main Hospital /ID# 217481
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
West Virginia University Hospitals /ID# 217344
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Medical College of Wisconsin /ID# 215610
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Royal Adelaide Hospital /ID# 216953
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of Calgary - Foothills Medical Centre /ID# 214790
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Name
QEII - Health Sciences Centre /ID# 215249
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital Civic Campus /ID# 215270
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Western Hospital /ID# 215214
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 240917
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
NHO Nagoya Medical Center /ID# 239617
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Funabashi Municipal Medical Center /ID# 225599
City
Funabashi-shi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Murayama Medical Center /ID# 223492
City
Musashimurayama-shi
State/Province
Tokyo
ZIP/Postal Code
2080011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141
City
Iizuka-shi
ZIP/Postal Code
820-8508
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital /ID# 241119
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inha University Hospital /ID# 238890
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 216384
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 217794
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 225354
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 225692
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Nacional de Paraplejicos /ID# 225508
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 217797
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
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)
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