Secondary progressive multiple sclerosis MedDRA version: 8.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Conditions
Interventions
Product Name: MBP8298 Synthetic Peptide
Product Code: MBP8298
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Dirucotide acetate
CAS Number: 781666-30-6
Current Sponsor code: MBP8298
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Sponsors
BioMS Technology Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, 18-65 years of age, 2. Documented history of SPMS. SPMS is defined as an MS patient who has been diagnosed with MS for at least 3 years, and in the 3 year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS). (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes will be acceptable). The subject must also have experienced at least 1 acute relapse as part of their diagnosis of RRMS. Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial MRI findings consistent with the diagnosis of MS are also present. 3. Absence of relapse in the 3 months prior to baseline. 4. EDSS of 3 . 5 – 6 . 5. 5. Pyramidal or Cerebellar FSS = 3 6. A cohort of 100 HLA DR2/4 negative patients is required. Once enrollement to this cohort is complete, all further patients are required to be HLA DR2/4 positive. 7. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements, 8. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Primary Progressive MS. 2. Subjects have previously received MBP8298. 3. A recent history of malignancy, with the exclusion of basal cell carcinoma. All patients with a history of malignancy must be discussed, approved and a waiver issued by the Sponsors' Medical Monitor prior to randomisation. 4. Steroid therapy within 30 days prior to first dose, or any other treatment known to be used for putative or experimental MS treatment. 5. Therapy with ß-interferon, glatiramer acetate within 3 months, mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment. 6. Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period. 7. History of anaphylactic/anaphylactoid reactions to glatiramer acetate, 8. Abnormal laboratory values at the Baseline Visit deemed by the Investigator to be clinically significant. 9. Known allergy to Gadolinium-DTPA. 10. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20. 11. Treatment at any time with an altered peptide ligand. 12. Any conditions that could interfere with the performance of study specific procedures e.g. MRI. 13. Previous randomization to this study. 14. Known positivity for HIV, Hepatitis B, or Hepatitis C. 15. Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test (the screening/baseline visit), or any investigational therapy in the past 6 months. 16. Females who are breast feeding, pregnant (pregnancy test at Screening), or not using a medically approved method of contraception regularly. 17. Known or suspected current or past alcohol or drug abuse (within the last year). 18. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements. 19. Any other condition that, in the Investigator’s opinion, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of 500 mg MBP8298 given intravenously every six months for a period of two years, to placebo, in subjects diagnosed with SPMS who are positive for the HLA DR2 and/or DR4 haplotype. Clinical efficacy is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS. ;Secondary Objective: •To assess safety of MBP8298 synthetic peptide in all subjects irrespective of genotype. •To compare the clinical efficacy of 500 mg MBP8298 given intravenously every six months for a period of two years, to placebo, in subjects diagnosed with SPMS who are negative for the HLA DR2 and/or DR4 haplotype. •To assess the effects of MBP8298 on MRI parameters. •To confirm that treatment with MBP8298 induces immunological tolerance or shift in functional response profile to MBP peptide (82-98) and determine whether this is dependent on HLA subtype •To determine whether MBP8298 induces immunological tolerance or shift in functional response profile to other MBP epitopes and other myelin antigens (e.g. PLP, MOG) indicating the stop of epitope spreading and whether this too is dependent on HLA subtype. •To confirm the ratio of HLA DR2/4 positive to HLA DR2/4 negative subjects in the SPMS population. •To determine whether MBP8298 improves the quality of life of SPMS patients. ;Primary end point(s): The primary endpoint is a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS. | — |
Countries
Denmark, Estonia, Finland, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed