BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis

NCT00382629 | Completed Phase 2

• 1 other identifier: BHT-3009-03
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Interventions

BHT-3009 0.5 mg DRUG

BHT-3009 1.5 mg DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayhill Therapeutics: lead

Related Links

• Bayhill website

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

BHT 3009

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frank Valone, MD

  Bayhill Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 29, 2006
• Study Start: February 1, 2006
• Study Completion: June 1, 2007
• Last Updated: February 11, 2008

Record last verified: 2008-02