Multiple Sclerosis (MS)Phase 2NCT03737812
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
A Phase 2 study testing elezanumab in people with Multiple Sclerosis (MS), run by AbbVie at 37 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- elezanumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 27 Feb 2019to 30 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States30 sites
Integrated Neurology Services /ID# 202743
Alexandria, Virginia, 22310
University of Colorado School of Medicine, Dept of Neurology /ID# 202807
Aurora, Colorado, 80045-2527
Duplicate_Parexel International /ID# 202747
Baltimore, Maryland, 21225
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
Berkeley, California, 94705-2017
The Research Center of Southern California /ID# 202802
Carlsbad, California, 92011-4213
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
Chaska, Minnesota, 55318-4551
Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
Dallas, Texas, 75243-1188
Michigan Institute for Neurological Disorders (MIND) /ID# 202470
Farmington Hills, Michigan, 48334
Advanced Neurosciences Research, LLC /ID# 203072
Fort Collins, Colorado, 80528
Advanced Neurosciences Institute /ID# 204555
Franklin, Tennessee, 37064
KCA Neurology - Franklin /ID# 202912
Franklin, Tennessee, 37067-5914
Vladimir Royter MD /ID# 202483
Hanford, California, 93230-5787
Evergreen Neuroscience Institute /ID# 204205
Kirkland, Washington, 98034-3029
Cleveland Clinic Lou Ruvo Cent /ID# 204744
Las Vegas, Nevada, 89106-0100
Rowe Neurology Institute /ID# 202744
Lenexa, Kansas, 66214
International Neurorehabilitation Institute /ID# 213333
Lutherville, Maryland, 21093-6016
Froedtert Memorial Lutheran Hospital /ID# 202618
Milwaukee, Wisconsin, 53226-3522
West Virginia Univ School Med /ID# 202849
Morgantown, West Virginia, 26506
Oklahoma Med Res. Foundation /ID# 203442
Oklahoma City, Oklahoma, 73104
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
Owosso, Michigan, 48867-2116
Stanford MS Center /ID# 202445
Palo Alto, California, 94304-1416
St. Josephs Hospital and Med Center /ID# 202809
Phoenix, Arizona, 85013
Providence Neurological Specialties - West /ID# 203193
Portland, Oregon, 97225-6646
Central Texas Neurology Consul /ID# 203108
Round Rock, Texas, 78681
UC Davis Health-Neurological Surgery /ID# 202485
Sacramento, California, 95817-2307
UCSF School of Medicine - Neurology /ID# 203194
San Francisco, California, 94143-0003
Virginia Mason Medical Center /ID# 205439
Seattle, Washington, 98101
Swedish MS Center /ID# 202904
Seattle, Washington, 98122-5698
Washington University-School of Medicine /ID# 202899
St Louis, Missouri, 63110
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
St Louis, Missouri, 63131-2322
Canada7 sites
Recherche Sepmus Inc. /ID# 212852
Greenfield Park, Quebec, J4V 2J2
Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
London, Ontario, N6A 5A5
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
Montreal, Quebec, H2X 0A9
Montreal Neurological Institut /ID# 203868
Montreal, Quebec, H3A 2B4
Ottawa Hospital Research Institute /ID# 203058
Ottawa, Ontario, K1H 8L6
Unity Health Toronto - St. Michael's Hospital /ID# 206213
Toronto, Ontario, M5B 1W8
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
Vancouver, British Columbia, V6T 1Z3
About this study
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
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- elezanumab, placebo
- Keywords
- Progressive multiple sclerosis, Elezanumab, ABT-555
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elezanumabDrug
Also called ABT-555
solution for infusion
placeboDrug
solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants randomized to receive placebo by intravenous infusion. Receives: Drug: placebo |
| Elezanumab 400mg Dose | Experimental | Participants randomized to receive 400mg of elezanumab by intravenous infusion. Receives: Drug: elezanumab |
| Elezanumab 1800 mg Dose | Experimental | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. Receives: Drug: elezanumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Overall Response Score (ORS)
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).
Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1.
The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
Measured: Week 52
Secondary outcomes (4)
Disability Improvement Response Rate
Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).
Measured: Week 52
Overall Response Score (ORS)
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).
Measured: Week 12
Overall Response Score (ORS)
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).
Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1.
The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.
Measured: Week 24
Overall Response Score (ORS)
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).
Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1.
The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.
Measured: Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start27 Feb 2019
- Primary completion15 Jan 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737812
- Sponsor's protocol ID
- M14-397
- Status last verified
- Dec 2023
- First submitted
- 6 Nov 2018
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03737812
- Acronym / sponsor ID
- M14-397
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Progressive multiple sclerosis, Elezanumab, ABT-555
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboParticipants randomized to receive placebo by intravenous infusion. |
| Elezanumab 400mg Dose | Experimental | Drug: elezanumabParticipants randomized to receive 400mg of elezanumab by intravenous infusion. |
| Elezanumab 1800 mg Dose | Experimental | Drug: elezanumabParticipants randomized to receive 1800mg of elezanumab by intravenous infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elezanumabAlso: ABT-555solution for infusion | Drug | Elezanumab 1800 mg Dose, Elezanumab 400mg Dose |
| placebosolution for infusion | Drug | Placebo |
Primary outcome
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). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
4 secondary outcomes
Disability Improvement Response Rate
Time frame: Week 52
Overall Response Score (ORS)
Time frame: Week 12
Overall Response Score (ORS)
Time frame: Week 24
Overall Response Score (ORS)
Time frame: Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing elezanumab in people with Multiple Sclerosis (MS), run by AbbVie at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Overall Response Score (ORS) (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.