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A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03737812
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with progressive Multiple Sclerosis (PMS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Drug: elezanumab Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : September 17, 2020
Estimated Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to receive double-blind placebo by intravenous infusion.
Drug: placebo
solution for infusion

Experimental: Elezanumab Dose 1
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
Drug: elezanumab
solution for infusion
Other Name: ABT-555

Experimental: Elezanumab Dose 2
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
Drug: elezanumab
solution for infusion
Other Name: ABT-555




Primary Outcome Measures :
  1. Overall Response Score (ORS) at Week 52 [ Time Frame: Week 52 ]
    The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).


Secondary Outcome Measures :
  1. 12-week confirmed disability improvement response rate on the Expanded Disability Status Scale Plus (EDSS+) [ Time Frame: 52 weeks ]
    12-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 12 weeks during the treatment period 52-weeks. The EDSS+ is used to assess severity of symptoms of MS and includes the Timed 25 Foot Walk (T25FW), 9-Hole Peg test in either hand (9HPT), and EDSS.

  2. 12-week confirmed disability improvement response rate on Timed 25 Foot Walk (T25FW) [ Time Frame: 52 weeks ]
    12-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 12 weeks during the treatment period 52-weeks. The T25FW is a tool that evaluates mobility and leg function performance.

  3. 12-week confirmed disability improvement response rate on 9-Hole Peg Test in either hand (9HPT) [ Time Frame: 52 weeks ]
    12-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 12 weeks during the treatment period 52-weeks. The 9HPT is a tool that evaluates upper extremity function.

  4. 12-week confirmed disability improvement response rate on Expanded Disability Status Scale (EDSS) [ Time Frame: 52 weeks ]
    12-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 12 weeks during the treatment period 52-weeks. The EDSS is a tool for quantifying disability in multiple sclerosis and monitoring changes in the level of disability.

  5. 24-week confirmed disability improvement response rate on the Expanded Disability Status Scale Plus (EDSS+) [ Time Frame: 52 weeks ]
    24-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 24 weeks during the treatment period 52-weeks. The EDSS+ is used to assess severity of symptoms of MS and includes the Timed 25 Foot Walk (T25FW), 9-Hole Peg test in either hand (9HPT), and EDSS.

  6. 24-week confirmed disability improvement response rate on Timed 25 Foot Walk (T25FW) [ Time Frame: 52 weeks ]
    24-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 24 weeks during the treatment period 52-weeks. The T25FW is a tool that evaluates mobility and leg function performance.

  7. 24-week confirmed disability improvement response rate on 9-Hole Peg Test in either hand (9HPT) [ Time Frame: 52 weeks ]
    24-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 24 weeks during the treatment period 52-weeks. The 9HPT is a tool that evaluates upper extremity function.

  8. 24-week confirmed disability improvement response rate on Expanded Disability Status Scale (EDSS) [ Time Frame: 52 weeks ]
    24-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 24 weeks during the treatment period 52-weeks. The EDSS is a tool for quantifying disability in multiple sclerosis and monitoring changes in the level of disability.

  9. Overall Response Score (ORS) at Week 12 [ Time Frame: Week 12 ]
    The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).

  10. Overall Response Score (ORS) at Week 24 [ Time Frame: Week 24 ]
    The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).

  11. Overall Response Score (ORS) at Week 36 [ Time Frame: Week 36 ]
    The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).

  12. Time to first improvement on 12-week confirmed Expanded Disability Status Scale Plus (EDSS+) [ Time Frame: 52 weeks ]
    12-week confirmed disability improvement is defined as a patient who showed an improvement in the EDSS+ and maintained the improvement for at least 12 weeks during the treatment period 52-weeks. The EDSS+ is used to assess severity of symptoms of MS and includes the Timed 25 Foot Walk (T25FW), 9-Hole Peg test in either hand (9HPT), and EDSS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months
  • Subject has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test

Exclusion Criteria:

  • Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification
  • Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab

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): NCT03737812


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03737812     History of Changes
Other Study ID Numbers: M14-397
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Progressive multiple sclerosis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases