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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963611
• Other study ID #: EMR200575-001
• Secondary ID: 2013-002283-25
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2013
• Last updated: July 24, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Plovamer acetate 0.5 milligram (mg)
Plovamer acetate will be administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
• Copaxone 20 mg
Copaxone will be administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
• Plovamer acetate 3 mg
Plovamer acetate will be administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
• Plovamer acetate 10 mg
Plovamer acetate will be administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
• Plovamer acetate 20 mg
Plovamer acetate will be administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.

Locations

Country	Name	City	State
Bulgaria	Research site	Blagoevgrad
Bulgaria	Research site	Dupnitsa
Bulgaria	Research site	Sofia
Croatia	Research site	Osijek
Croatia	Research site	Varazdin
Croatia	Research site	Zagreb
Czech Republic	Research site	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
Finland	Research site	Kuopio
Finland	Research site	Oulu
Finland	Research site	Turku
Greece	Research site	Athens
Greece	Research site	Thessaloniki
Hungary	Research site	Budapest
Hungary	Research site	Debrecen
Hungary	Research site	Esztergom
Hungary	Research site	Miskolc
Italy	Research site	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
Mexico	Research site	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
Poland	Research site	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
Russian Federation	Research site	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
Serbia	Research site	Belgrade
Serbia	Research site	Kragujevac
Serbia	Research site	Nis
South Africa	Research site	Cape Town
South Africa	Research site	Durban
South Africa	Research site	Pretoria
Spain	Research site	Aranjuez
Spain	Research site	Córdoba
Spain	Research site	Madrid
Spain	Research site	Mostoles
Spain	Research site	Santander
Spain	Research site	Zaragoza
Turkey	Research site	Diyarbakir
Turkey	Research site	Edirne
Turkey	Research site	Istanbul
Turkey	Research site	Kocaeli
Turkey	Research site	Mersin
Turkey	Research site	Samsun
Ukraine	Research site	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
United Kingdom	Research site	Exeter
United Kingdom	Research site	Hull
United Kingdom	Research site	Sheffield
United Kingdom	Research site	Southampton
United Kingdom	Research site	Stoke on Trent
United States	Research site	Baltimore	Maryland
United States	Research site	Charlotte	North Carolina
United States	Research site	Cincinnati	Ohio
United States	Research site	Columbus	Georgia
United States	Research site	Dayton	Ohio
United States	Research site	Detroit	Michigan
United States	Research Site	Detroit	Michigan
United States	Research site	Dover	Delaware
United States	Research site	Elk Grove Village	Illinois
United States	Research site	Fairfield	Connecticut
United States	Research site	Golden Valley	Minnesota
United States	Research site	Hickory	North Carolina
United States	Research site	Indianapolis	Indiana
United States	Research site	Matthews	North Carolina
United States	Research site	Miami	Florida
United States	Research site	Naples	Florida
United States	Research site	Nashville	Tennessee
United States	Research site	New Bedford	Massachusetts
United States	Research site	Plainview	New York
United States	Research site	Pompano Beach	Florida
United States	Research site	Raleigh	North Carolina
United States	Research site	Redding	California
United States	Research site	Roanoke	Virginia
United States	Research site	Rome	Georgia
United States	Research Site	Round Rock	Texas
United States	Research Site	San Antonio	Texas
United States	Research site	San Diego	California
United States	Research site	San Diego	California
United States	Research site	Sarasota	Florida
United States	Research site	St Louis	Missouri
United States	Research site	Sunrise	Florida
United States	Research site	Tacoma	Washington
United States	Research site	Willow Grove	Pennsylvania
United States	Research site	Wilmington	North Carolina
United States	Research site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Czech Republic,  Finland,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of Time Constant 1 (T1) Gadolinium (Gd)-enhancing lesions per subject and scan from 5 serial magnetic resonance imaging (MRI) scans on Weeks 24, 28, 32, 36 and 40		Up to Week 40	No
Secondary	Mean annualized relapse rate (ARR)		Up to Week 40	No
Secondary	Percentage of subjects remaining relapse-free		Week 40	No
Secondary	Mean number of new T1 Gd-enhancing lesions per subject and scan from 5 serial MRI scans		Weeks 24, 28, 32, 36, and 40	No
Secondary	Mean number of new or enlarging Time Constant 2 (T2) lesions per subject and scan from 5 serial MRI scans		Weeks 24, 28, 32, 36, and 40	No
Secondary	Mean number of new, unenhancing T1 lesions (black holes) per subject and scan from 5 serial MRIs		Weeks 24, 28, 32, 36, and 40	No
Secondary	Mean change in volume of T1 Gd-enhancing lesions per subject, baseline versus mean of 5 serial MRI scans at Weeks 24, 28, 32, 36, and 40		Baseline, Weeks 24, 28, 32, 36, and 40	No
Secondary	Mean change per subjects in volume of T2 Gd-enhancing lesions baseline versus last MRI scan between Weeks 24 and 40		Baseline, Weeks 24, 28, 32, 36, and 40	No
Secondary	Time to first relapse		Up to Week 40	No
Secondary	Mean change in brain volume per subject, baseline versus last MRI performed between Weeks 24 and 40		Baseline, Weeks 24, 28, 32, 36, and 40	No