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BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

BHT-3009 0.5 mg

BHT-3009 1.5 mg

Placebo

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple sclerosis, MS, Bayhill, BHT-3009, immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Definite diagnosis of multiple sclerosis by the McDonald criteria.
Screening cranial MRI demonstrating lesions consistent with MS.
One or more relapses within the previous year.
Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period.
EDSS 0 to 3.5 inclusive.
Age > 17 years and < 56 years.
Willing and able to give informed consent.
WBC >3,000; platelets >100,000; hemoglobin > 10.0 g/dl.
AST, ALT, bilirubin < 2.0 x upper limit of normal.
Creatinine < 2.0 x upper limit of normal.
Negative test for HIV.

Exclusion Criteria:

Primary progressive, secondary progressive or progressive relapsing MS.
More than 5 gadolinium-enhancing lesions on the first screening MRI.
High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures.
Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
Treatment with an approved disease modifying agent within 180 days of beginning screening procedures.
Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.)
Prior therapy with natalizumab (Tysabri).
Pregnant or lactating women.
Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner).
Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia).
Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
Known hypersensitivity or allergy to gadolinium.

Sites / Locations

Outcomes

Primary Outcome Measures

Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.

Secondary Outcome Measures

Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.

Evaluate the effect of BHT-3009 on other cranial MRI measures.

Describe the effect of BHT-3009 therapy on relapse rate.

Describe the effect of BHT-3009 on subject disability scores.

Full Information

NCT ID

NCT00382629

First Posted

September 27, 2006

Last Updated

February 7, 2008

Sponsor

Bayhill Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00382629

Brief Title

BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

Official Title

BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bayhill Therapeutics

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.

Detailed Description

People with multiple sclerosis are thought to have abnormal immunity. Usually the body's immune system attacks only foreign substances, but people with MS have abnormal immunity, where the immune system attacks normal proteins, one of which is a protein found in the brain called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are circular pieces of DNA that are being tested in clinical trials for their ability to alter patients' immune systems. Two different doses of BHT-3009 will be tested to determine if there are any differences in their safety or effects on inflammation. Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4 weeks for a total of 13 doses in 44 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple sclerosis, MS, Bayhill, BHT-3009, immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

252 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

BHT-3009 0.5 mg

Intervention Type

Drug

Intervention Name(s)

BHT-3009 1.5 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.

Secondary Outcome Measure Information:

Title

Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.

Title

Evaluate the effect of BHT-3009 on other cranial MRI measures.

Title

Describe the effect of BHT-3009 therapy on relapse rate.

Title

Describe the effect of BHT-3009 on subject disability scores.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Definite diagnosis of multiple sclerosis by the McDonald criteria. Screening cranial MRI demonstrating lesions consistent with MS. One or more relapses within the previous year. Clinically stable (no relapses) for > 50 days before beginning screening procedures and during the screening period. EDSS 0 to 3.5 inclusive. Age > 17 years and < 56 years. Willing and able to give informed consent. WBC >3,000; platelets >100,000; hemoglobin > 10.0 g/dl. AST, ALT, bilirubin < 2.0 x upper limit of normal. Creatinine < 2.0 x upper limit of normal. Negative test for HIV. Exclusion Criteria: Primary progressive, secondary progressive or progressive relapsing MS. More than 5 gadolinium-enhancing lesions on the first screening MRI. High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures. Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy. Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents). Treatment with an approved disease modifying agent within 180 days of beginning screening procedures. Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.) Prior therapy with natalizumab (Tysabri). Pregnant or lactating women. Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner). Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia). Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints. Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans. Known hypersensitivity or allergy to gadolinium.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Valone, MD

Organizational Affiliation

Bayhill Therapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.bayhilltherapeutics.com

Description

Bayhill website

Learn more about this trial

BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

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