Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

April 5, 2016 updated by: EMD Serono

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Dupnitsa, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Croatia
      • Osijek, Croatia
        • Research Site
      • Varazdin, Croatia
        • Research Site
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Havirov, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Jihlava, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • Finland
      • Kuopio, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
  • Italy
      • Castelfiorentino, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Cefalù, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Modena, Italy
        • Research Site
      • Montichiari, Italy
        • Research Site
      • Parma, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Mexico
      • Cuautitlan Izcalli, Mexico
        • Research Site
      • Leon, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
      • Morelia, Mexico
        • Research Site
      • Tlalnepantla, Mexico
        • Research Site
  • Poland
      • Gdansk, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Rzeszow, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Research Site
      • Krasnoyarsk, Russian Federation
        • Research Site
      • Kursk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Research Site
      • Saransk, Russian Federation
        • Research Site
      • St Petersburg, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Nis, Serbia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Spain
      • Aranjuez, Spain
        • Research Site
      • Córdoba, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Mostoles, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • Turkey
      • Diyarbakir, Turkey
        • Research Site
      • Edirne, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Kocaeli, Turkey
        • Research Site
      • Mersin, Turkey
        • Research Site
      • Samsun, Turkey
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Zaporizhzhia, Ukraine
        • Research Site
  • United Kingdom
      • Exeter, United Kingdom
        • Research Site
      • Hull, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Southampton, United Kingdom
        • Research Site
      • Stoke on Trent, United Kingdom
        • Research Site
  • United States
    • California
      • Redding, California, United States, 96001
        • Research Site
      • San Diego, California, United States, 92128
        • Research Site
      • San Diego, California, United States, 92117
        • Research Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Research Site
    • Delaware
      • Dover, Delaware, United States, 19901
        • Research Site
    • Florida
      • Miami, Florida, United States, 33136
        • Research Site
      • Naples, Florida, United States, 34102
        • Research Site
      • Pompano Beach, Florida, United States, 33060
        • Research Site
      • Sarasota, Florida, United States, 34233
        • Research Site
      • Sunrise, Florida, United States, 33351
        • Research Site
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Research Site
      • Rome, Georgia, United States, 30165
        • Research Site
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Research Site
      • Detroit, Michigan, United States, 97205
        • Research Site
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site
    • New York
      • Plainview, New York, United States, 11803
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Research Site
      • Hickory, North Carolina, United States, 28602
        • Research Site
      • Matthews, North Carolina, United States, 28105
        • Research Site
      • Raleigh, North Carolina, United States, 27607-6010
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Research Site
      • Dayton, Ohio, United States, 45417
        • Research Site
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Research Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Experimental: Plovamer acetate 3 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 3 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Experimental: Plovamer acetate 10 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 10 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Experimental: Plovamer acetate 20 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Active Comparator: Copaxone 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Drug: Copaxone 20 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Frame: Baseline , Week 12, 24, 28, 32, 36, 40
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Baseline , Week 12, 24, 28, 32, 36, 40

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Annualized Relapse Rate (ARR)
Time Frame: Baseline up to Week 40
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).
Baseline up to Week 40
Percentage of Subjects Remaining Relapse-Free
Time Frame: Baseline up to Week 40
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.
Baseline up to Week 40
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Frame: Weeks 12, 24, 28, 32, 36, 40
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Weeks 12, 24, 28, 32, 36, 40
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Time Frame: Weeks 12, 24, 28, 32, 36,40
New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.
Weeks 12, 24, 28, 32, 36,40
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Time Frame: Weeks 12, 24, 28, 32, 36, 40
New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.
Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.
Baseline, Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.
Baseline, Weeks 12, 24, 28, 32, 36, 40
Time to First Relapse
Time Frame: Baseline up to Week 40
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.
Baseline up to Week 40
Mean Change From Baseline in Brain Volume Per Subject
Time Frame: Baseline, Weeks 24, 28, 32, 36, 40
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Baseline, Weeks 24, 28, 32, 36, 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Investigators

  • Study Director: Medical Responsible, EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200575-001
  • 2013-002283-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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