Relapsing Remitting Multiple Sclerosis
Conditions
Interventions
Product Name: MBP8298 Synthetic Peptide
Product Code: MBP8298
Pharmaceutical Form: Powder for injection*
CAS Number: 781666-30-6
Current Sponsor code: MBP8298
Other descriptive name: MBP8298 Synthetic
Sponsors
BioMS Technology Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, 18-50 years of age 2. Relapsing-remitting multiple sclerosis (RRMS) according to “Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria” (Annals of Neurology 58: 840-846) 3. At least 2 years history of MS before trial entry 4. Documented history of 2 or more exacerbations in the 2 years prior to trial entry 5. Stable neurological status for at least 30 days before first study drug administration 6. Have an EDSS from 0-5.5 7. If female, she must either - be post-menopausal or surgically sterilized; or - use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and - be neither pregnant nor breast-feeding 8. Willingness and ability to comply with the protocol for the duration of the study 9. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations 10. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements Are the trial subjects under 18? 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS) 2. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma 3. Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC), 4. Clinically significant ECG abnormalities at screening 5. Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1) 6. Have current autoimmune disease, compromised immune function or infection 7. History of allergic reactions to glatiramer acetate 8. Steroid therapy within 30 days prior to first study specific procedure, or any other treatment known to be used for putative or experimental MS treatment 9. Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test 10. Therapy with 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 11. Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20, 12. Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium-DTPA 13. Participation in any other trial of an investigational agent within 90 days prior to screening 14. History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening 15. 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 16. 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: The primary objective of this study is to demonstrate efficacy - as measured with annualized relapse rate after 12 months treatment - and safety of MBP8298 versus placebo in subjects diagnosed with RRMS and who are positive for HLA DR2/4 haplotypes. ;Secondary Objective: The secondary objective of this study is to assess efficacy and safety of MBP8298 versus placebo in subjects who are negative for HLA DR2/4 haplotypes and to assess in all subjects the time to confirmed worsening of disability as measured by EDSS and MSFC and the effects of MBP8298 on MRI parameters like • Activity analysis (T2 lesions, Gadolinium enhancing lesions) • Lesion burden (T2 burden of disease, chronic T1 black holes) • Brain Atrophy;Primary end point(s): Primary efficacy endpoints: The primary efficacy endpoint is the annualized relapse rate after 12 months of treatment. The secondary efficacy endpoints: A. Main Secondary endpoints a. Clinical related endpoints Disability related Disability progression defined as the time to confirmed worsening of disability as measured by EDSS and MSFC at 12 24 and 27 months Exacerbation (relapse) related • Proportion of subjects relapse-free at 12, 24 and 27 months b. MRI related endpoints • Number of active lesions per subject per scan defined as new T1 gadolinium-enhancing, or new T2 non-enhancing or enlarging lesions at all MRI follow-up visits (designated “combined unique activity”) • Number of active T2 lesions per subject per scan at the end of first and second year • Number of active T1 gadolinium-enhanced lesions per subject per scan at the end of first and second year B. Other secondary endpoints (exploratory) a. Clinical related endpoints Exacerbation (relapse) related • Number of hospitalizations because of exacerbation at 12, 24 and 27 months • Duration of exacerbations • Severity of exacerbations as assessed with EDSS • Time to first exacerbation • Time to second exacerbation • Time from first to second exacerbatio | — |
Countries
Slovakia
Outcome results
None listed