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

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Plovamer acetate 3 mg; Drug: Copaxone 20 mg; Drug: Plovamer acetate 20 mg; Drug: Plovamer acetate 10 mg; Drug: Plovamer acetate 0.5 milligram (mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01963611

EMR200575-001

2013-002283-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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255 participants in 5 patient groups

Plovamer acetate 0.5 milligram (mg)

Experimental group

Description:

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.

Treatment:

Drug: Plovamer acetate 0.5 milligram (mg)

Plovamer acetate 3 mg

Experimental group

Description:

Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Treatment:

Drug: Plovamer acetate 3 mg

Plovamer acetate 10 mg

Experimental group

Description:

Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Treatment:

Drug: Plovamer acetate 10 mg

Plovamer acetate 20 mg

Experimental group

Description:

Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

Treatment:

Drug: Plovamer acetate 20 mg

Copaxone 20 mg

Active Comparator group

Description:

Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Treatment:

Drug: Copaxone 20 mg