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

Phase 2

Terminated

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: Plovamer acetate 0.5 milligram (mg); Drug: Plovamer acetate 3 mg; Drug: Plovamer acetate 10 mg; Drug: Plovamer acetate 20 mg; Drug: Copaxone 20 mg

• Registration Number: NCT01963611
• Lead Sponsor: EMD Serono

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-04
• Results First Submitted: 2016-04-05
• Results First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-05
• Results First Posted: 2016-05-11
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 255

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plovamer acetate 0.5 milligram (mg)	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.
Plovamer acetate 3 mg	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.
Plovamer acetate 10 mg	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.
Plovamer acetate 20 mg	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.
Copaxone 20 mg	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Remaining Relapse-Free	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.
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan	Weeks 12, 24, 28, 32, 36, 40	T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan	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.
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan	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.
Time to First Relapse	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.
Mean Change From Baseline in Brain Volume Per Subject	Baseline, Weeks 24, 28, 32, 36, 40	Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan	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.
Mean Annualized Relapse Rate (ARR)	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).
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan	Weeks 12, 24, 28, 32, 36, 40	New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.

Trial Locations

Locations (2)

Research Site; 🇺🇸 San Antonio, Texas, United States

Research site; 🇬🇧 Stoke on Trent, United Kingdom