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)

NCT04295538 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: M16-0772019-003752-36
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 41

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  Up to approximately 91 Weeks

Secondary Outcomes (2)

• Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score

  Week 0 through Week 52

• Change in Upper Extremity Motor Score (UEMS) From Baseline

  Week 0 through Week 52

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for elezanumab

Drug: Placebo

Elezanumab

EXPERIMENTAL

Participants will receive elezanumab dose A

Drug: Elezanumab

Interventions

Elezanumab DRUG

Solution for infusion; Intravenous (IV)

Also known as: ABT-555

Elezanumab

Placebo DRUG

Solution for infusion; Intravenous (IV)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (41)

University of California Davis Health /ID# 224892

Sacramento, California, 95817, United States

Location

Shepherd Center, Inc /ID# 230370

Atlanta, Georgia, 30309-1426, United States

Location

Northwestern University Feinberg School of Medicine /ID# 218009

Chicago, Illinois, 60611-2927, United States

Location

University of Louisville Hospital /ID# 215948

Louisville, Kentucky, 40202, United States

Location

Duplicate_Tufts Medical Center /ID# 225410

Boston, Massachusetts, 02111, United States

Location

Brigham & Women's Hospital /ID# 216342

Boston, Massachusetts, 02115, United States

Location

Duplicate_Boston University School of Medicine /ID# 218371

Boston, Massachusetts, 02118-2515, United States

Location

Beth Israel Deaconess Medical Center /ID# 218149

Boston, Massachusetts, 02215-5400, United States

Location

Regents of the University of Michigan /ID# 215890

Ann Arbor, Michigan, 48109-1276, United States

Location

Washington University-School of Medicine /ID# 215325

St Louis, Missouri, 63110, United States

Location

Hackensack Univ Med Ctr /ID# 215754

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center /ID# 218162

Neptune City, New Jersey, 07753-4859, United States

Location

Rutgers New Jersey School of Medicine /ID# 216212

Newark, New Jersey, 07103, United States

Location

Duplicate_Duke Cancer Center /ID# 216888

Durham, North Carolina, 27710-3000, United States

Location

Oregon Medical Research Center /ID# 227371

Portland, Oregon, 97239, United States

Location

University of Pennsylvania /ID# 218662

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Thomas Jefferson University Hospital /ID# 215460

Philadelphia, Pennsylvania, 19107, United States

Location

University of Virginia Health /ID# 218117

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital /ID# 218302

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Medical Center Main Hospital /ID# 217481

Richmond, Virginia, 23219, United States

Location

West Virginia University Hospitals /ID# 217344

Morgantown, West Virginia, 26506, United States

Location

Wisconsin Medical Center /ID# 215610

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital /ID# 216953

Adelaide, South Australia, 5000, Australia

Location

Foothills Medical Centre /ID# 214790

Calgary, Alberta, T2N 2T9, Canada

Location

QEII - Health Sciences Centre /ID# 215249

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Ottawa Hospital Civic Campus /ID# 215270

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto Western Hospital /ID# 215214

Toronto, Ontario, M5T 2S8, Canada

Location

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

Montreal, Quebec, H4J 1C5, Canada

Location

The Chaim Sheba Medical Center /ID# 240917

Ramat Gan, Tel Aviv, 5265601, Israel

Location

NHO Nagoya Medical Center /ID# 239617

Nagoya, Aichi-ken, 460-0001, Japan

Location

Funabashi Municipal Medical Center /ID# 225599

Funabashi-shi, Chiba, 273-8588, Japan

Location

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

Iizuka-shi, Fukuoka, 820-8508, Japan

Location

National Hospital Organization Murayama Medical Center /ID# 223492

Musashimurayama-shi, Tokyo, 2080011, Japan

Location

Ajou University Hospital /ID# 241119

Suwon, Gyeonggido, 16499, South Korea

Location

Duplicate_Inha University Hospital /ID# 238890

Junggu, Incheon Gwang Yeogsi, 22332, South Korea

Location

Complejo Hospitalario Universitario A Coruña /ID# 216384

A Coruña, A Coruna, 15006, Spain

Location

Hospital Universitario Vall de Hebron /ID# 217794

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre /ID# 225354

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 225692

Seville, 41013, Spain

Location

Hospital Nacional de Paraplejicos /ID# 225508

Toledo, 45071, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 217797

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

elezanumab

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 4, 2020
• Study Start: September 6, 2020
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

AU (1); US (22); IL (1); ES (6); CA (5); JP (4); KR (2)