E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with current diagnosis of SP-MS |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063400 |
E.1.2 | Term | Secondary progressive multiple sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <7. 7. Subjects must be willing and able to comply with the protocol requirements. 8. With the exception of signs and symptoms that directly relate to their MS, subjects must be in good general health, without significant medical history, physical examination findings, or clinically-significant abnormal laboratory results. 9. Subjects must have a negative alcohol breathalyzer test and a urine screen for drugs of abuse at the Screening Visit.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |