A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-002283-25-CZ
• Date of registration: 26/09/2013
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis
• Scientific 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 - Efficacy, safety, and tolerability of plovamer acetate
• Date of first enrolment: 18/12/2013
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002283-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Rater blinded If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 5

Countries of recruitment

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

Contacts

• Name: Communication Centre merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Centre merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, between the ages of 18 and 60 years.
2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).

Other protocol defined inclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
2. Any relapse of MS within 30 days of the Baseline Visit 2.
3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. 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.)
5. Contraindication to Copaxone use.

Other protocol defined exclusion criteria could apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Product Name: Plovamer acetate
Product Code: MSC2491529A
Pharmaceutical Form: Solution for injection
Current Sponsor code: MSC2491529A
Other descriptive name: Plovamer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Copaxone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
CAS Number: 147245-92-9
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): 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).

Secondary Objective: To evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg), administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment

Timepoint(s) of evaluation of this end point: 40 weeks

Main Objective: The primary objective of this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 40 weeks

Secondary end point(s): Mean Annualized Relapse Rate.
· Percentage of patients remaining relapse-free at
Week 40.
· Mean number of new T1 Gd-enhancing lesions per
patient and scan from 5 serial MRI scans performed on
Weeks 24, 28, 32, 36, and 40.
· Mean number of new or enlarging T2 lesions per patient and scan from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean number of new, unenhancing T1 lesions (black holes) per patient and scan on MRI scans from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
· Mean change in volume of T1 Gd-enhancing lesions per patient baseline vs. mean of 5 serial MRI scans performed on Weeks 24, 28, 32, 36, and 40.
· Mean change per patient in volume of T2 Gd-enhancing lesions baseline vs. last MRI scan performed between Weeks 24 and 40.
· Time to first relapse.
· Mean change in brain volume per patient baseline vs. last MRI performed between Weeks 24 and 40.

Secondary ID(s)

EMR200575-001

Source(s) of Monetary Support

Merck KGaA