None listed
Conditions
Brief summary
This is a Phase II multi-centre, double-blind, placebo-controlled study. The purpose of this study is to test an experimental oral drug called ovine IFN-tau, to see if it is a safe and effective treatment for relapsing-remitting MS. IFN-tau is similar in activity to the currently-approved beta interferons, but can be taken orally (in liquid form) instead of by injection. The double blind method is designed to eliminate biased results; as this study is double-blind in design, participants will be randomised by a computer generated randomisation system, to either the experimental or the control group. Neither the participants nor the researchers will know which participants belong to the control group or the experimental group. This study aims to test two different doses of IFN-tau (3mg and 6mg/day), comparing each dose with (inactive) placebo. Up to 90 people will test the drug in this study. In order to do so, a new brain lesion consistent with MS must be demonstrated on MRI. Patients may have up to three, monthly, brain MRIs (taken at monthly intervals) to determine their eligibility. Other screening tests will include physical examination, chest x-ray and electrocardiogram. Participants have a nearly 67% chance of receiving IFN-tau (2:1 over placebo). The first 45 participants enrolled will test the 6mg/day dose of IFN-tau; and the next 45 participants enrolled will test the 3mg/day dose. Participants in each dose group will take the study medication daily for a total of 168 days. Patients return to the clinic at week 1 and then monthly for six months, where safety and monitoring tests and an MRI are performed. A follow up visit occurs 3mths after the last dose of study medication. Reported adverse events of the drug include headaches, weakness and back pain.
Interventions
3.0 mg oral administration of either Recombinant Ovine Interferon-Tau (treatment group), once or twice daily for 6 months (168 days) plus 3 months follow up
Sponsors
PEPGEN Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must be willing to avoid other interferons during the 6-month treatment period and the 3-month follow-up period unless the patient experiences a relapse or exacerbation of their condition; patients must not have received interferon-betas within 90 days prior to first pre-treatment MRI; patients must not have received steroids within 30 days and Copaxone within 90 days prior to the first pre-treatment MRI; patients must not have received Tysabri; patients must read, understand and sign the study Informed Consent Form prior to any participation in the study; Patients must have a clinical diagnosis of relapsing-remitting multiple sclerosis; patients must be willing to avoid steroids and Copaxone during the 6-month treatment period and the 3-month follow-up period; patients must have at least one new Gadolinium-enhanced lesion as revealed from one of three screening MRIs taken four weeks apart prior to enrollment and treatment.
Exclusion criteria
Pregnant or nursing women; patients who were non-responders to treatment with interferon-beta (patients who discontinued interferon-beta because of clinical MRI disease activity while on interferon-beta are NOT eligible); patients who have received steroids within 30 days and Copaxone within 90 days prior to the first pre-treatment MRI; patients who have received immunosuppressive agents within 1-year of treatment; patients who have received Tysabri; patients who have received investigational drug therapy during the 6-month treatment period; hematopoietic dysfunction within 10 days of treatment (absolute neutrophil count less than the lower limit of normal; lymphocyte differential less than the lower limit of normal; Hgb less than the lower limit of normal; platelet count less than 100,000); Coagulation dysfunction within 10 days of treatment (PTT and PT greater than 1.5 times the upper limit of normal); Hepatic dysfunction within 10 days of treatment (Bilirubin greater than 1.5 times the upper limit of normal; AST/ALT and alkaline phosphatase greater than 2 times the upper limit of normal; history of hepatic cirrhosis or hepatic disease requiring current treatment); Renal dysfunction within 10 days of treatment (Creatinine greater than 1.5 times upper limit of normal; renal disease requiring current treatment); Cardiovascular dysfunction (myocardinal infarction within 6 months of study treatment; presence of significant coronary artery disease requiring current treatment); Pulmonary dysfunction within 3 months of treatment (dyspnea due to obstructive pulmonary disease); presence of sepsis; presence of any phsical or psychiatric condition that is likely to detrimentally affect treatment or follow-up of patient according to the protocol; history of drug or alcohol abuse within 6 months of the study entry; patients with 15 or more Gadolinium-enhanced lesions in any of 3 screening MRIs.
Outcome results
None listed