Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000241538
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
15/06/2006
Date last updated
26/10/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy Study of Oral IFN-tau in Patients with Relapsing-Remitting Multiple Sclerosis
Scientific title
Phase II Multi-centre, Double-Blind, Randomized, Placebo-Controlled Safety and Efficacy Study of Oral Recombinant Ovine Interferon-Tau (IFN-tau) Administered Daily in Patients with Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 270 0
PEPGEN Corporation: OvIFN-0601A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 1218 0
Condition category
Condition code
Neurological 1302 1302 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1085 0
Treatment: Drugs
Comparator / control treatment
Placebo (control group)
Control group
Placebo

Outcomes
Primary outcome [1] 1782 0
Number of new Gadolinium-enhanced lesions as revealed from Magnetic Resonance Imaging (MRI) scans
Timepoint [1] 1782 0
Weeks -9, -5, -1, and study days 29, 57, 83, 113, 141, 169 and 253.
Secondary outcome [1] 3135 0
Immunological assessment (Th1 related molecules, Th2 related molecules, Th3 related molecules, T reg molecules, Tr1 related molecules).
Timepoint [1] 3135 0
Weeks 9 and 1, and study days 29, 57, 85, 113, 141, 169 and 253.
Secondary outcome [2] 3136 0
Multiple Sclerosis Quality of Life Questionnaire
Timepoint [2] 3136 0
Study days 1 and 169

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to group is done via a computer generated central randomization system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization, stratified by site, will be used to ensure allocation concealment. Block size is not variable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 325 0
United States of America
State/province [1] 325 0

Funding & Sponsors
Funding source category [1] 1429 0
Commercial sector/Industry
Name [1] 1429 0
PEPGEN Corporation
Country [1] 1429 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
PEPGEN Corporation
Address
1301 Harbor Bay Parkway, Suite 100
Alameda, CA 94502
Country
United States of America
Secondary sponsor category [1] 1257 0
Other
Name [1] 1257 0
National Stroke Research Institute trading as Neuroscience Trials Australia
Address [1] 1257 0
Level 1 Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country [1] 1257 0
Australia

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36173 0
Address 36173 0
Country 36173 0
Phone 36173 0
Fax 36173 0
Email 36173 0
Contact person for public queries
Name 10274 0
Ms Jennifer Coleman
Address 10274 0
Level A, 3kz Building
Austin Health
Heidelberg, Vic 3084
Country 10274 0
Australia
Phone 10274 0
+61 3 94963705
Fax 10274 0
+61 3 94572654
Email 10274 0
jennifer.coleman@austin.org.au
Contact person for scientific queries
Name 1202 0
Dennis Gilman
Address 1202 0
1301 Harbor Bay Parkway
Suite 100
Alameda CA 94502
Country 1202 0
United States of America
Phone 1202 0
+1 775 8251997
Fax 1202 0
+1 775 8256744
Email 1202 0
dpgilman@icrcnv.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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