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) (ELASCI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

24 Jul 2020 → 27 Jan 2026

Decision date (initial)

2023-11-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-505125-14-00

EudraCT number

2019-003752-36

ClinicalTrials.gov

NCT04295538

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the safety and efficacy of elezanumab in subjects with acute traumatic cervical SCI.

Conditions and MedDRA coding

Acute Traumatic Cervical Spinal Cord Injury

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects or their legally authorized representative must voluntarily provide informed consent before the initiation of any study-specific procedure in a form approved by an independent ethics committee (IEC)/institutional review board (IRB). In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
2. Adult male or female, between 18 and 75 years of age, inclusive.
3. Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 (cervical lesion as defined by first ISNCSCI) with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator's opinion, would significantly limit recovery.
4. Maximum screening UEMS of 32.
5. AIS grade A or B at Screening.
6. Able to initiate study drug administration within 24 hours of injury.
7. Subjects 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.

Exclusion criteria 4

1. Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT). CT required only for subjects suspected to have a brain injury at the discretion of the investigator.
2. Must not have 1 or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
3. No 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.
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the Upper Extremity Motor Score (UEMS), a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2019 criteria) during the Treatment Period.

Secondary endpoints 2

1. Spinal Cord Independence Measures (SCIM III) self-care score
2. UEMS change from baseline

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications