Safety and Efficacy Study of Oral IFN-tau in Patients with Relapsing-Remitting Multiple Sclerosis

Phase 2

• Conditions: Multiple sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12606000241538
• Lead Sponsor: PEPGEN Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of new Gadolinium-enhanced lesions as revealed from Magnetic Resonance Imaging (MRI) scans[Weeks -9, -5, -1, and study days 29, 57, 83, 113, 141, 169 and 253.]

Secondary Outcome Measures

Name	Time	Method
Immunological assessment (Th1 related molecules, Th2 related molecules, Th3 related molecules, T reg molecules, Tr1 related molecules).[Weeks 9 and 1, and study days 29, 57, 85, 113, 141, 169 and 253.];Multiple Sclerosis Quality of Life Questionnaire[Study days 1 and 169]