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Expanded Access to Elezanumab

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ClinicalTrials.gov Identifier: NCT04278235
Expanded Access Status : Available
First Posted : February 20, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or disease Intervention/treatment
Acute Spinal Cord Injury (SCI) Acute Ischemic Stroke Multiple Sclerosis (MS) Drug: Elezanumab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Elezanumab

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Elezanumab
    Solution for intravenous (IV) infusion
    Other Name: ABT-555
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- The participant must not be eligible for an elezanumab clinical trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278235


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04278235    
Other Study ID Numbers: C20-203
C20-284 ( Other Grant/Funding Number: AbbVie )
C20-285 ( Other Grant/Funding Number: AbbVie )
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
 Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Multiple Sclerosis
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries