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Spinal Cord Injury (SCI)Phase 2ELASCINCT04295538

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)

A Phase 2 study testing Elezanumab in people with Spinal Cord Injury (SCI), run by AbbVie at 41 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Spinal Cord Injury (SCI)
What is being tested?
Elezanumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
41 sitesin 7 countries
Study dates
6 Sep 2020to 26 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

41 sites in 7 countries.

41 sites in 7 countries

United States22 sites

  • Regents of the University of Michigan /ID# 215890

    Ann Arbor, Michigan, 48109-1276

  • Shepherd Center, Inc /ID# 230370

    Atlanta, Georgia, 30309-1426

  • Duplicate_Tufts Medical Center /ID# 225410

    Boston, Massachusetts, 02111

  • Brigham & Women's Hospital /ID# 216342

    Boston, Massachusetts, 02115

  • Duplicate_Boston University School of Medicine /ID# 218371

    Boston, Massachusetts, 02118-2515

  • Beth Israel Deaconess Medical Center /ID# 218149

    Boston, Massachusetts, 02215-5400

  • University of Virginia Health /ID# 218117

    Charlottesville, Virginia, 22908

  • Northwestern University Feinberg School of Medicine /ID# 218009

    Chicago, Illinois, 60611-2927

  • Duplicate_Duke Cancer Center /ID# 216888

    Durham, North Carolina, 27710-3000

  • Hackensack Univ Med Ctr /ID# 215754

    Hackensack, New Jersey, 07601

  • University of Louisville Hospital /ID# 215948

    Louisville, Kentucky, 40202

  • Wisconsin Medical Center /ID# 215610

    Milwaukee, Wisconsin, 53226

  • West Virginia University Hospitals /ID# 217344

    Morgantown, West Virginia, 26506

  • Jersey Shore University Medical Center /ID# 218162

    Neptune City, New Jersey, 07753-4859

  • Rutgers New Jersey School of Medicine /ID# 216212

    Newark, New Jersey, 07103

  • Sentara Norfolk General Hospital /ID# 218302

    Norfolk, Virginia, 23507

  • University of Pennsylvania /ID# 218662

    Philadelphia, Pennsylvania, 19104-5502

  • Thomas Jefferson University Hospital /ID# 215460

    Philadelphia, Pennsylvania, 19107

  • Oregon Medical Research Center /ID# 227371

    Portland, Oregon, 97239

  • Virginia Commonwealth University Medical Center Main Hospital /ID# 217481

    Richmond, Virginia, 23219

  • University of California Davis Health /ID# 224892

    Sacramento, California, 95817

  • Washington University-School of Medicine /ID# 215325

    St Louis, Missouri, 63110

Other trials in United States

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 216384

    A Coruña, A Coruna, 15006

  • Hospital Universitario Vall de Hebron /ID# 217794

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre /ID# 225354

    Madrid, 28041

  • Hospital Universitario Virgen del Rocio /ID# 225692

    Seville, 41013

  • Hospital Nacional de Paraplejicos /ID# 225508

    Toledo, 45071

  • Hospital Universitario y Politecnico La Fe /ID# 217797

    Valencia, 46026

Other trials in Spain

Canada5 sites

  • Foothills Medical Centre /ID# 214790

    Calgary, Alberta, T2N 2T9

  • QEII - Health Sciences Centre /ID# 215249

    Halifax, Nova Scotia, B3H 2Y9

  • CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210

    Montreal, Quebec, H4J 1C5

  • The Ottawa Hospital Civic Campus /ID# 215270

    Ottawa, Ontario, K1Y 4E9

  • Toronto Western Hospital /ID# 215214

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Japan4 sites

  • Funabashi Municipal Medical Center /ID# 225599

    Funabashi-shi, Chiba, 273-8588

  • Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141

    Iizuka-shi, Fukuoka, 820-8508

  • National Hospital Organization Murayama Medical Center /ID# 223492

    Musashimurayama-shi, Tokyo, 2080011

  • NHO Nagoya Medical Center /ID# 239617

    Nagoya, Aichi-ken, 460-0001

Other trials in Japan

South Korea2 sites

  • Duplicate_Inha University Hospital /ID# 238890

    Junggu, Incheon Gwang Yeogsi, 22332

  • Ajou University Hospital /ID# 241119

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Australia1 site

  • Royal Adelaide Hospital /ID# 216953

    Adelaide, South Australia, 5000

Other trials in Australia

Israel1 site

  • The Chaim Sheba Medical Center /ID# 240917

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

About this study

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

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.

Read more

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.

Being tested
Elezanumab, Placebo
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
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElezanumabDrug

    Also called ABT-555

    Solution for infusion; Intravenous (IV)

  • PlaceboDrug

    Solution for infusion; Intravenous (IV)

Study groups in NCT04295538
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo for elezanumab
Receives: Drug: Placebo
ElezanumabExperimentalParticipants will receive elezanumab dose A
Receives: Drug: Elezanumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 52 Weeks

  2. Number of Participants Experiencing Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 91 Weeks

Secondary outcomes (2)

  1. 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.

    Measured: Week 0 through Week 52

  2. 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.

    Measured: Week 0 through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start6 Sep 2020
  3. Primary completion26 Jan 2026
  4. Study completion26 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295538
Sponsor's protocol ID
M16-077
Other IDs
2019-003752-36, 2019
Acronym
ELASCI
Status last verified
Feb 2026
First submitted
3 Mar 2020
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elezanumab in people with Spinal Cord Injury (SCI), run by AbbVie at 41 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Spain, Canada, Japan, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity Motor Score (UEMS) (time frame: 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04295538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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