Patients with current diagnosis of SP-MS MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Conditions
Interventions
Product Name: PI-2301
Product Code: CO-14
Pharmaceutical Form: Solution for injection
CAS Number: 1026791-33-1
Current Sponsor code: PI-2301
Other descriptive name: CO-14
Concentration unit: mg/ml mil
Sponsors
PEPTIMMUNE Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between the ages of 18 and 60 (inclusive) who have signed an approved, informed consent document. 2. Patients must have a current diagnosis of SP-MS with duration of diagnosis of at least 1 year and less than 10 years from the baseline examination. 3. Female subjects must not be pregnant or lactating. If of childbearing potential, subjects must decide in conjunction with their physician on a double contraceptive method that they will use in order to avoid being pregnant since at least 14 days before their entry in the study as well as throughout the duration of the study. 4. If a female subject is unable to bear children, this must be documented on the Case Report Form (CRF; e.g., tubal ligation, hysterectomy, postmenopausal). Postmenopausal is defined as a minimum of 1 year since the last menstrual period. 5. Subject must have evidence of MS obtained by MRI (T1 weighted imaging with gadolinium contrast) using a 1.5 Tesla magnet within 1 year of the baseline examination with =10 active gadolinium enhancing lesions). 6. EDSS of = 3 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Currently or within the past 5 years, history of malignancy other than squamous or basal cell carcinoma of the skin. 2. A current diagnosis or recent history within 2 years of alcoholism; drug abuse; or severe emotional, behavioral, or psychiatric problems that would hinder adequate compliance with study requirements. 3. History of clinically significant gastrointestinal, renal, hepatic, endocrinic, oncologic, pulmonary or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, psychosis, glaucoma; or any other condition, which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 4 Clinically significant abnormality on screening or baseline ECG (allowable abnormalities: occasional premature atrial beats, abnormal PR interval not associated w/ SVT or heart block, RBBB, resting ST =100 or SB = 50). 5. A positive pregnancy test at the Screening Visit (serum test) or Day 1, prior to drug administration (urine test). 6. MRI at Screening showing >10 CNS gadolinium-enhancing lesions on T1 scans consistent with Multiple Sclerosis, using a 1.5 Tesla magnet. 7. Any relapse of multiple sclerosis within the prior 3 months. 8. Immunosuppression due to acquired immunodeficiency syndrome (AIDS), or cancer chemotherapy within the 6 months prior to the Screening Visit, or other etiology of immunosuppression. 9. History or evidence of hepatitis B or C. 10. Participation in a previous investigational drug or device study within 30 days preceding the Screening Visit. 11. History of any prior Copaxone®, Cellcept, Tysabri, or Campath use. 12. History of total lymphoid irradiation. 13. History within the prior 3 months prior to the Screening Visit of glucocorticoid therapy. 14. History within the prior 6 months prior to the Screening Visit of any of the following: azathioprine, cladribine, cyclophosphamide, cyclosporine, interferon beta-1a or interferon beta-1b, methotrexate, or mitoxantrone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and tolerability of 4 to 6 dose levels of PI 2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Secondary Objective: The secondary objectives of this study are to evaluate the pharmacokinetics, effects on immunological/biological markers, magnetic resonance imaging (MRI), and the Expanded Disability Status Scale (EDSS) of 4 to 6 dose levels of PI-2301 in subjects with SP-MS when administered weekly for up to 12 weeks;Primary end point(s): Safety parameters : Safety will be monitored with using physical examinations, vital signs, ECGs, laboratory testing, and AE/SAE assessments. Particular attention will be focused on monitoring for anaphylaxis or hypersensitivity reactions, systemic inflammatory response syndrome (SIRS), and injection site reaction (ISR). | — |
Countries
Hungary
Outcome results
None listed