BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: BHT-3009 0.5 mg Drug: BHT-3009 1.5 mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Bayhill Therapeutics:

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.

Estimated Enrollment:	252
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382629

Sponsors and Collaborators

Bayhill Therapeutics

Investigators

Study Director:

Frank Valone, MD

Bayhill Therapeutics

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00382629 History of Changes
Other Study ID Numbers:	BHT-3009-03
Study First Received:	September 27, 2006
Last Updated:	February 7, 2008
Health Authority:	United States: Food and Drug Administration Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Poland: Ministry of Health Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayhill Therapeutics:

Multiple sclerosis
MS
Bayhill
BHT-3009
immunotherapy

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Pathologic Processes
Butylated Hydroxytoluene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013