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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03737851
Recruitment Status : Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE December 11, 2018
Estimated Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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 EDSThe 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • 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 (9HPT, either hand), and EDSS.
  • 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.
  • 12-week confirmed disability improvement response rate on 9-Hole Peg Test (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.
  • 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.
  • 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 (9HPT, either hand), and EDSS.
  • 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.
  • 24-week confirmed disability improvement response rate on 9-Hole Peg Test (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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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 (9HPT, either hand), and EDSS.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Brief Summary The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with relapsing Multiple Sclerosis (RMS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis (MS)
Intervention  ICMJE
  • Drug: elezanumab
    solution for infusion
    Other Name: ABT-555
  • Drug: placebo
    solution for infusion
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants randomized to receive double-blind placebo by intravenous infusion.
    Intervention: Drug: placebo
  • Experimental: Elezanumab Dose 1
    Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
    Intervention: Drug: elezanumab
  • Experimental: Elezanumab Dose 2
    Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
    Intervention: Drug: elezanumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
208
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
165
Estimated Study Completion Date  ICMJE October 4, 2021
Estimated Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months
  • Subject has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS)
  • 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:

  • Subjects must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737851
Other Study ID Numbers  ICMJE M18-918
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP