ANZCTR - Registration

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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]

PEPGEN Corporation: OvIFN-0601A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple sclerosis

Condition category

Condition code

Neurological

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]

Treatment: Drugs

Comparator / control treatment

Placebo (control group)

Control group

Placebo

Outcomes

Primary outcome [1]

Number of new Gadolinium-enhanced lesions as revealed from Magnetic Resonance Imaging (MRI) scans

Timepoint [1]

Weeks -9, -5, -1, and study days 29, 57, 83, 113, 141, 169 and 253.

Secondary outcome [1]

Immunological assessment (Th1 related molecules, Th2 related molecules, Th3 related molecules, T reg molecules, Tr1 related molecules).

Timepoint [1]

Weeks 9 and 1, and study days 29, 57, 85, 113, 141, 169 and 253.

Secondary outcome [2]

Multiple Sclerosis Quality of Life Questionnaire

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

PEPGEN Corporation

Address [1]

1301 Harbor Bay Parkway, Suite 100
Alameda, CA 94502

Country [1]

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]

Other

Name [1]

National Stroke Research Institute trading as Neuroscience Trials Australia

Address [1]

Level 1 Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Jennifer Coleman

Address

Level A, 3kz Building
Austin Health
Heidelberg, Vic 3084

Country

Australia

Phone

+61 3 94963705

Fax

+61 3 94572654

jennifer.coleman@austin.org.au

Contact person for scientific queries

Name

Dennis Gilman

Address

1301 Harbor Bay Parkway
Suite 100
Alameda CA 94502

Country

United States of America

Phone

+1 775 8251997

Fax

+1 775 8256744

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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