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Multiple Sclerosis (MS)Phase 2NCT03737851

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

A Phase 2 study testing elezanumab in people with Multiple Sclerosis (MS), run by AbbVie at 49 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS). 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
208 participants
Where
49 sitesin 2 countries
Study dates
11 Dec 2018to 9 Sep 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

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

  • Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United States42 sites

  • Integrated Neurology Services, PLLC /ID# 204261

    Alexandria, Virginia, 22310

  • University of Colorado School of Medicine /ID# 204250

    Aurora, Colorado, 80045-2527

  • Duplicate_Parexel International /ID# 204273

    Baltimore, Maryland, 21225

  • The NeuroMedical Center /ID# 204253

    Baton Rouge, Louisiana, 70810

  • Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249

    Berkeley, California, 94705-2017

  • University of Alabama at Birmingham - Main /ID# 204618

    Birmingham, Alabama, 35233

  • Pediatric Endocrine Associates /ID# 204279

    Boston, Massachusetts, 02114

  • The Research Center of Southern California /ID# 204269

    Carlsbad, California, 92011-4213

  • Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383

    Chaska, Minnesota, 55318-4551

  • The University of Chicago Medical Center /ID# 205319

    Chicago, Illinois, 60637-1443

  • Neurology Consultants of Dallas - LBJ Fwy /ID# 204398

    Dallas, Texas, 75243-1188

  • Michigan Institute for Neurological Disorders (MIND) /ID# 204194

    Farmington Hills, Michigan, 48334

  • Advanced Neurosciences Research, LLC /ID# 204289

    Fort Collins, Colorado, 80528

  • Advanced Neurosciences Institute /ID# 204557

    Franklin, Tennessee, 37064

  • KCA Neurology - Franklin /ID# 204208

    Franklin, Tennessee, 37067-5914

  • Vladimir Royter MD /ID# 204392

    Hanford, California, 93230-5787

  • UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418

    Houston, Texas, 77030-1501

  • Indiana Univ School Medicine /ID# 204891

    Indianapolis, Indiana, 46202

  • UC Irvine Health /ID# 205728

    Irvine, California, 92697

  • Tri-State Mountain Neurology /ID# 204252

    Johnson City, Tennessee, 37604

  • Evergreen Neuroscience Institute /ID# 204203

    Kirkland, Washington, 98034-3029

  • Cleveland Clinic Lou Ruvo Cent /ID# 204745

    Las Vegas, Nevada, 89106-0100

  • Rowe Neurology Institute /ID# 204391

    Lenexa, Kansas, 66214

  • Dr. Bhupesh Dihenia, MD, PA /ID# 207839

    Lubbock, Texas, 79410

  • International Neurorehabilitation Institute /ID# 213332

    Lutherville, Maryland, 21093-6016

  • Froedtert Memorial Lutheran Hospital /ID# 204202

    Milwaukee, Wisconsin, 53226-3522

  • West Virginia Univ School Med /ID# 204292

    Morgantown, West Virginia, 26506

  • Ochsner Medical Center /ID# 204189

    New Orleans, Louisiana, 70121-2429

  • Oklahoma Med Res. Foundation /ID# 204389

    Oklahoma City, Oklahoma, 73104

  • Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328

    Owosso, Michigan, 48867-2116

  • Stanford MS Center /ID# 204283

    Palo Alto, California, 94304-1416

  • Thomas Jefferson University /ID# 204281

    Philadelphia, Pennsylvania, 19107

  • St. Josephs Hospital and Med Center /ID# 204197

    Phoenix, Arizona, 85013

  • Providence Neurological Specialties - West /ID# 204248

    Portland, Oregon, 97225-6646

  • Central Texas Neurology Consul /ID# 204268

    Round Rock, Texas, 78681

  • UC Davis Health-Neurological Surgery /ID# 204188

    Sacramento, California, 95817-2307

  • UCSF School of Medicine - Neurology /ID# 204251

    San Francisco, California, 94143-0003

  • Virginia Mason Medical Center /ID# 205440

    Seattle, Washington, 98101

  • Swedish MS Center /ID# 204198

    Seattle, Washington, 98122-5698

  • University of Washington Medicine MS Center /ID# 205852

    Seattle, Washington, 98133-8400

  • Washington University-School of Medicine /ID# 204388

    St Louis, Missouri, 63110

  • The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433

    St Louis, Missouri, 63131-2322

Other trials in United States

Canada7 sites

  • Recherche Sepmus Inc. /ID# 212851

    Greenfield Park, Quebec, J4V 2J2

  • Duplicate_London Health Sciences Centre - University Hospital /ID# 204848

    London, Ontario, N6A 5A5

  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844

    Montreal, Quebec, H2X 0A9

  • Montreal Neurological Institut /ID# 204843

    Montreal, Quebec, H3A 2B4

  • Ottawa Hospital Research Institute /ID# 204842

    Ottawa, Ontario, K1H 8L6

  • Unity Health Toronto - St. Michael's Hospital /ID# 206214

    Toronto, Ontario, M5B 1W8

  • University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

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 Relapsing Forms of Multiple Sclerosis

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).

Being tested
elezanumab, placebo
Keywords
Relapsing multiple sclerosis, Multiple sclerosis, Elezanumab, ABT-555
Medical subject headings
Multiple Sclerosis

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 groups in NCT03737851
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants randomized to receive double-blind placebo by intravenous infusion.
Receives: Drug: placebo
Elezanumab Dose 1ExperimentalParticipants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
Receives: Drug: elezanumab
Elezanumab Dose 2ExperimentalParticipants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
Receives: Drug: elezanumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Overall Response Score (ORS) at 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.

    Measured: Week 52

Secondary outcomes (4)

  1. Disability Improvement Response Rate

    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).

    Measured: Week 52

  2. 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 12

  3. 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

  4. 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.

  1. First posted13 Nov 2018
  2. Study start11 Dec 2018
  3. Primary completion9 Aug 2021
  4. Study completion9 Sep 2021

Resources

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
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737851
Sponsor's protocol ID
M18-918
Status last verified
Dec 2023
First submitted
6 Nov 2018
Last updated
22 Dec 2023
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.

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 49 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 3 inclusion and 1 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 22 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 49 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 22 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) at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03737851.

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 22 Dec 2023.

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