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Efficacy, safety, and tolerability of plovamer acetate

A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis
Stopped earlyPhase 2Relapsing MSNCT019636112013-002283-25

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Study was terminated based on sponsor discretion.

What was tested

Treatment tested

  • Plovamer acetate 0.5 milligram (mg)
  • Plovamer acetate

    HLA class II histocompatibility antigen, DRB1-15 beta chain modulator

Compared with

Results by group

Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

Baseline , Week 12, 24, 28, 32, 36, 40

GroupValueIntervalNumber analysed
Plovamer Acetate 0.5 Milligram (mg)1.5 lesions per subjects per scan2.93 (Standard Deviation)45
Plovamer Acetate 3 mg1.6 lesions per subjects per scan4.12 (Standard Deviation)45
Plovamer Acetate 10 mg1.0 lesions per subjects per scan2.43 (Standard Deviation)43
Plovamer Acetate 20 mg2.3 lesions per subjects per scan5.65 (Standard Deviation)41
Copaxone 20 mg2.5 lesions per subjects per scan5.12 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)1.7 lesions per subjects per scan3.28 (Standard Deviation)45
Plovamer Acetate 3 mg1.3 lesions per subjects per scan3.55 (Standard Deviation)45
Plovamer Acetate 10 mg1.2 lesions per subjects per scan2.4 (Standard Deviation)43
Plovamer Acetate 20 mg1.5 lesions per subjects per scan3.7 (Standard Deviation)41
Copaxone 20 mg1.7 lesions per subjects per scan4.51 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)1.5 lesions per subjects per scan2.53 (Standard Deviation)45
Plovamer Acetate 3 mg0.9 lesions per subjects per scan2.33 (Standard Deviation)45
Plovamer Acetate 10 mg1.5 lesions per subjects per scan4.14 (Standard Deviation)43
Plovamer Acetate 20 mg1.1 lesions per subjects per scan1.92 (Standard Deviation)41
Copaxone 20 mg0.6 lesions per subjects per scan1.46 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)1.7 lesions per subjects per scan2.75 (Standard Deviation)45
Plovamer Acetate 3 mg0.4 lesions per subjects per scan0.92 (Standard Deviation)45
Plovamer Acetate 10 mg0.5 lesions per subjects per scan1.2 (Standard Deviation)43
Plovamer Acetate 20 mg2.0 lesions per subjects per scan4 (Standard Deviation)41
Copaxone 20 mg0.9 lesions per subjects per scan1.89 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)1.0 lesions per subjects per scan1.41 (Standard Deviation)45
Plovamer Acetate 3 mg0.2 lesions per subjects per scan0.41 (Standard Deviation)45
Plovamer Acetate 10 mg0.8 lesions per subjects per scan1.72 (Standard Deviation)43
Plovamer Acetate 20 mg1.8 lesions per subjects per scan3.33 (Standard Deviation)41
Copaxone 20 mg1.2 lesions per subjects per scan3.67 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)0.0 lesions per subjects per scan45
Plovamer Acetate 3 mgNot reached45
Plovamer Acetate 10 mg1.0 lesions per subjects per scan1.41 (Standard Deviation)43
Plovamer Acetate 20 mg1.3 lesions per subjects per scan2.31 (Standard Deviation)41
Copaxone 20 mg7.3 lesions per subjects per scan12.7 (Standard Deviation)44
Plovamer Acetate 0.5 Milligram (mg)0.0 lesions per subjects per scan45
Plovamer Acetate 3 mgNot reached45
Plovamer Acetate 10 mg0.0 lesions per subjects per scan43
Plovamer Acetate 20 mg0.0 lesions per subjects per scan41
Copaxone 20 mg16.0 lesions per subjects per scan44

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Plovamer Acetate 0.5 Milligram (mg)512 (3.9%)
Plovamer Acetate 3 mg490 (0.0%)
Plovamer Acetate 10 mg522 (3.8%)
Plovamer Acetate 20 mg523 (5.8%)
Copaxone 20 mg500 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

    Baseline , Week 12, 24, 28, 32, 36, 40

    MRI lesions

  • The primary endpoint is the mean number of T1 Gd-enhancing lesions per patient per scan measured over 5 monthly visits (Weeks 24, 28, 32, 36 and 40).

    MRI lesions

Other measures (10)

  • Mean Annualized Relapse Rate (ARR)

    Baseline up to Week 40

    Disability progressionRelapsesSafety

  • Percentage of Subjects Remaining Relapse-Free

    Baseline up to Week 40

    Disability progressionRelapsesSafety

  • Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

    Weeks 12, 24, 28, 32, 36, 40

    MRI lesions

  • Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan

    Weeks 12, 24, 28, 32, 36,40

    MRI lesions

  • Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan

    Weeks 12, 24, 28, 32, 36, 40

    MRI lesions

  • Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

    Baseline, Weeks 12, 24, 28, 32, 36, 40

    MRI lesions

  • Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

    Baseline, Weeks 12, 24, 28, 32, 36, 40

    MRI lesions

  • Time to First Relapse

    Baseline up to Week 40

    Disability progressionRelapsesSafety

  • Mean Change From Baseline in Brain Volume Per Subject

    Baseline, Weeks 24, 28, 32, 36, 40

    MRI lesionsBrain volume loss

  • Mean Annualized Relapse Rate.

    Relapses

Who could take part

Relapsing MS · 18 to 60

Inclusion Criteria: * Male or female, between the ages of 18 and 60 years * Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject) * Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing * Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI * Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed) * Contraindication to Copaxone use * Other protocol defined exclusion criteria could apply

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

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History

    1. Started

      Oct 2013

    2. Main results due

      Mar 2015

    3. Finished

      Mar 2015

    4. Results posted

      May 2016

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