Multiple sclerosis therapy with transdermal myelin peptide stimulation.

• Register: EUCTR
• Last refreshed on: 29 January 2018
• Main ID: EUCTR2016-002180-33-PL
• Date of registration: 14/07/2016
• Prospective Registration: Yes
• Primary sponsor: Centrum Neurologii Krzysztof Selmaj
• Public title: Multiple sclerosis therapy with transdermal myelin peptide stimulation.
• Scientific title: Multiple sclerosis therapy with transdermal myelin peptide stimulation.
• Date of first enrolment: 16/11/2016
• Target sample size: 220
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002180-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: yes; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Poland

Contacts

• Name: contact point information
• Affiliation: Centrum Neurologii Krzysztof Selmaj

• Name: contact point information
• Affiliation: Centrum Neurologii Krzysztof Selmaj

Key inclusion & exclusion criteria

Inclusion criteria:
The signing of informed consent to participate in the study
Women and men aged 18-60 years
RR diagnosis of MS according to the McDonald criteria 2010
State disability by EDSS 0 to 5.5
At least one relapse in the 12 months prior to screening
Neurologically stable during the 30 days prior to screening

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 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with diagnosis of SP MS and PP MS.
Pregnant patients
Patients with active immune system diseases, rheumatoid arthritis, scleroderma, Crohn's disease, etc.
Patients with bone marrow dysfunction, significant anemia, leukopenia, neutropenia, thrombocytopenia
Patients with active infection, bacterial, fungal or viral
Patients with AIDS
Patients with a history of syphilis, tuberculosis, hepatitis B or C
Patients vaccinated with a live or attenuated vaccine within 2 months prior to screening
Patients treatment with steroids or ACTH during the 30 days prior to screening
Patients treated in the past with interferon beta who discontinued treatment due to inefficiency
Patients with natalizumab treatment during the 6 months prior to screening
Patients treated with mitoxantrone 2 years before screening
Patients treated with fingolimod or dimethyl fumarate 2 months prior to screening
Patients with a history of cancer other than basal cell carcinoma
Patients with significant underlying cardiovascular, respiratory, gastrointestinal tract, kidney.
Patients who are unable to undergo MRI
Patients with a history of hyperactivity / allergy skin



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

Intervention(s)

Product Name: SMderpept
Pharmaceutical Form: Powder for cutaneous solution
INN or Proposed INN: PLP peptide
Current Sponsor code: PLP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: MBP peptide
Current Sponsor code: MBP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: MOG peptide
Current Sponsor code: MOG peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: SMderpept
Pharmaceutical Form: Powder for cutaneous solution
INN or Proposed INN: PLP peptide
Current Sponsor code: PLP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: MBP peptide
Current Sponsor code: MBP peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: MOG peptide
Current Sponsor code: MOG peptide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Avonex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta 1-A
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: Secondary objectives :
- cumulative number of gadolinium positive changes in MRI
- new / enlarging changes in the MRI T2 sequence
- number of new changes in the MRI T1 sequence
- change in MTR factor

Main Objective: The demonstration that myelin MBP85-99, MOG 35-55 PLP139-151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A.

Primary end point(s): The demonstration that myelin MBP85-99, MOG 35-55 PLP139-151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A.

Timepoint(s) of evaluation of this end point: every patient visit

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12,24,36,48,60,72,84,96 week

Secondary end point(s): - cumulative number of gadolinium positive changes in MRI
- new / enlarging changes in the MRI T2 sequence
- number of new changes in the MRI T1 sequence
- change in MTR factor

Secondary ID(s)

SMderpept

Source(s) of Monetary Support

The National Centre for Research and Development