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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04295538




Registration number
NCT04295538
Ethics application status
Date submitted
3/03/2020
Date registered
4/03/2020
Date last updated
30/11/2020

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2019-003752-36
Secondary ID [2] 0 0
M16-077
Universal Trial Number (UTN)
Trial acronym
ELASCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury (SCI) 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Elezanumab
Treatment: Drugs - Placebo

Experimental: Elezanumab - Participants will receive elezanumab dose A

Placebo Comparator: Placebo - Participants will receive placebo for elezanumab


Treatment: Drugs: Elezanumab
Solution for infusion; Intravenous (IV)

Treatment: Drugs: Placebo
Solution for infusion; Intravenous (IV)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
52 Weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 0 through Week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 0 through Week 52

Eligibility
Key inclusion criteria
- Acute traumatic cervical 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital /ID# 216953 - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
West Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Japan
State/province [17] 0 0
Chiba
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Japan
State/province [19] 0 0
Iizuka-shi
Country [20] 0 0
Spain
State/province [20] 0 0
A Coruna
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Sevilla
Country [23] 0 0
Spain
State/province [23] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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 18-70 years of age with a SCI will be enrolled.
Approximately 54 participants will be enrolled in the study in approximately 36 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.
Trial website
https://clinicaltrials.gov/show/NCT04295538
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04295538