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NCT03737812

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

Completed Phase 2 Results posted Last updated 21 December 2023
What this trial tests

Phase 2 trial testing elezanumab in Multiple Sclerosis (MS) in 123 participants. Completed in 30 August 2021.

Timeline
27 February 2019
Primary endpoint
15 January 2021
30 August 2021

Quick facts

Lead sponsorAbbVie
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment123
Start date27 February 2019
Primary completion15 January 2021
Estimated completion30 August 2021
Sites37 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis (MS). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Overall Response Score (ORS) Primary · 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.

GroupValue95% CI
Placebo-0.74± 0.167
Elezanumab 400mg Dose-0.75± 0.176
Elezanumab 1800 mg Dose-0.64± 0.170
Disability Improvement Response Rate Secondary · Week 52

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).

GroupValue95% CI
Placebo3
Elezanumab 400mg Dose7
Elezanumab 1800 mg Dose9
Overall Response Score (ORS) Secondary · 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).

GroupValue95% CI
Placebo-0.47± 0.134
Elezanumab 400mg Dose0.00± 0.136
Elezanumab 1800 mg Dose-0.21± 0.139
Overall Response Score (ORS) Secondary · 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). 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.

GroupValue95% CI
Placebo-0.28± 0.176
Elezanumab 400mg Dose-0.27± 0.194
Elezanumab 1800 mg Dose-0.53± 0.188
Overall Response Score (ORS) Secondary · 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). 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.

GroupValue95% CI
Placebo-0.45± 0.159
Elezanumab 400mg Dose-0.48± 0.178
Elezanumab 1800 mg Dose-0.52± 0.169

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 76 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 2/43 (5%)
Deaths: 1/43
Elezanumab 400mg Dose
Serious: 5/40 (13%)
Deaths: 1/40
Elezanumab 1800 mg Dose
Serious: 3/40 (8%)
Deaths: 0/40

Serious adverse events (20 terms)

ReactionSystemPlaceboElezanumab 400mg DoseElezanumab 1800 mg Dose
ATRIAL FIBRILLATIONCardiac disorders
HYPERTHYROIDISMEndocrine disorders
INTESTINAL PSEUDO-OBSTRUCTIONGastrointestinal disorders
CHILLSGeneral disorders
DEATHGeneral disorders
PYREXIAGeneral disorders
COVID-19 PNEUMONIAInfections and infestations
DIVERTICULITISInfections and infestations
PNEUMONIAInfections and infestations
SEPSISInfections and infestations
URINARY TRACT INFECTIONInfections and infestations
FALLInjury, poisoning and procedural complications
PATELLA FRACTUREInjury, poisoning and procedural complications
DIABETIC KETOACIDOSISMetabolism and nutrition disorders
HYPONATRAEMIAMetabolism and nutrition disorders
MUSCULAR WEAKNESSMusculoskeletal and connective tissue disorders
MULTIPLE SCLEROSIS RELAPSENervous system disorders
SYNCOPENervous system disorders
UHTHOFF'S PHENOMENONNervous system disorders
RESPIRATORY FAILURERespiratory, thoracic and mediastinal disorders
Other adverse events (37 terms — click to expand)

ReactionSystemPlaceboElezanumab 400mg DoseElezanumab 1800 mg Dose
URINARY TRACT INFECTIONInfections and infestations
FALLInjury, poisoning and procedural complications
INFUSION RELATED REACTIONInjury, poisoning and procedural complications
HEADACHENervous system disorders
FATIGUEGeneral disorders
MUSCULAR WEAKNESSMusculoskeletal and connective tissue disorders
PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders
COVID-19Infections and infestations
NASOPHARYNGITISInfections and infestations
ARTHRALGIAMusculoskeletal and connective tissue disorders
INSOMNIAPsychiatric disorders
HOT FLUSHVascular disorders
VERTIGOEar and labyrinth disorders
GASTROOESOPHAGEAL REFLUX DISEASEGastrointestinal disorders
PAINGeneral disorders
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations
JOINT SWELLINGMusculoskeletal and connective tissue disorders
MUSCLE SPASMSMusculoskeletal and connective tissue disorders
DIZZINESSNervous system disorders
HYPOAESTHESIANervous system disorders
MULTIPLE SCLEROSIS RELAPSENervous system disorders
NEURALGIANervous system disorders
DERMATITIS CONTACTSkin and subcutaneous tissue disorders
CONSTIPATIONGastrointestinal disorders
NAUSEAGastrointestinal disorders
VOMITINGGastrointestinal disorders
CHEST DISCOMFORTGeneral disorders
PYREXIAGeneral disorders
CELLULITISInfections and infestations
PNEUMONIAInfections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTIONInfections and infestations
MUSCLE SPASTICITYNervous system disorders
PARAESTHESIANervous system disorders
DEPRESSIONPsychiatric disorders
SLEEP DISORDERPsychiatric disorders
COUGHRespiratory, thoracic and mediastinal disorders
EPISTAXISRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: ATRIAL FIBRILLATION, HYPERTHYROIDISM, INTESTINAL PSEUDO-OBSTRUCTION, CHILLS, DEATH, PYREXIA, COVID-19 PNEUMONIA, DIVERTICULITIS.

Data from ClinicalTrials.gov NCT03737812 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Molecular Basis for Remyelination Failure in Multiple Sclerosis.
    Gruchot J, Weyers V, Göttle P, Förster M, et al · · 2019 · cited 79× · PMID 31382620 · DOI 10.3390/cells8080825
  2. Glial Cell-Axonal Growth Cone Interactions in Neurodevelopment and Regeneration.
    Rigby MJ, Gomez TM, Puglielli L. · · 2020 · cited 55× · PMID 32210757 · DOI 10.3389/fnins.2020.00203
  3. New insight on microglia activation in neurodegenerative diseases and therapeutics.
    Xu Y, Gao W, Sun Y, Wu M. · · 2023 · cited 22× · PMID 38188026 · DOI 10.3389/fnins.2023.1308345
  4. Breaking the barriers to remyelination in multiple sclerosis.
    Gharagozloo M, Bannon R, Calabresi PA. · · 2022 · cited 19× · PMID 35255453 · DOI 10.1016/j.coph.2022.102194
  5. An unmet clinical need: roads to remyelination in MS.
    Göttle P, Förster M, Weyers V, Küry P, et al · · 2019 · cited 19× · PMID 33324887 · DOI 10.1186/s42466-019-0026-0
  6. Multiple sclerosis: a narrative overview of current pharmacotherapies and emerging treatment prospects.
    Olejnik P, Roszkowska Z, Adamus S, Kasarełło K. · · 2024 · cited 17× · PMID 39177889 · DOI 10.1007/s43440-024-00642-0
  7. Translational Relevance of Secondary Intracellular Signaling Cascades Following Traumatic Spinal Cord Injury.
    Zavvarian MM, Modi AD, Sadat S, Hong J, et al · · 2024 · cited 5× · PMID 38891894 · DOI 10.3390/ijms25115708
  8. Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Studies to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing and Progressive Forms of Multiple Sclerosis.
    Cree BAC, Freedman MS, Gold M, Pfleeger K, et al · · 2025 · PMID 40698976 · DOI 10.1002/ana.27262

Verify or expand the search:

Other trials of elezanumab

Trials testing the same drug.

Other recruiting trials for Multiple Sclerosis (MS)

Currently open trials in the same condition.

Other AbbVie trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03737812.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing