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

• ClinicalTrials.gov Identifier: NCT03737812
• Recruitment Status: Completed
• First Posted: November 13, 2018
• Last Update Posted: December 20, 2021
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: November 6, 2018
• First Posted Date: November 13, 2018
• Last Update Posted Date: December 20, 2021
• Actual Study Start Date: February 27, 2019
• Actual Primary Completion Date: January 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 9, 2020)

Mean Overall Response Score (ORS) [ 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 (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).

Current Secondary Outcome Measures (submitted: December 9, 2020)

• Disability Improvement Response Rate [ Time Frame: Week 52 ]
  Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).
• Overall Response Score (ORS) [ Time Frame: Up to 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).

Original Secondary Outcome Measures (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 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 ]
  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 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
• 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
• Brief Summary: The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Multiple Sclerosis (MS)

Intervention

• Drug: elezanumab
  solution for infusion
  Other Name: ABT-555
• Drug: placebo
  solution for infusion

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2021): 123
• Original Estimated Enrollment (submitted: November 8, 2018): 90
• Actual Study Completion Date: August 30, 2021
• Actual Primary Completion Date: January 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03737812
• Other Study ID Numbers: M14-397
• Has Data Monitoring Committee: Yes

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

• 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)
• 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

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: December 2021