Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

NCT ID: NCT01199640

Last Updated: 2010-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-10-31

Brief Summary

This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MLN1202

Group Type: EXPERIMENTAL

MLN1202

Intervention Type: DRUG

Patients received 5 intravenous (IV) infusions of the study drug. The first 3 infusions were administered at 15-day intervals, followed by 2 infusions at 30-day intervals. Patients were randomized to receive 1 of 2 doses of MLN1202 (4mg/kg or 8mg/kg).

Interventions

MLN1202

Patients received 5 intravenous (IV) infusions of the study drug. The first 3 infusions were administered at 15-day intervals, followed by 2 infusions at 30-day intervals. Patients were randomized to receive 1 of 2 doses of MLN1202 (4mg/kg or 8mg/kg).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
• An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive
• Be willing and able to comply with the protocol for the duration of the study period
• Be willing to use adequate "double-barrier" contraceptive methods for the duration of the study period
• If female, must be neither pregnant or breast-feeding
• Written informed consent
• To be enrolled in the treatment phase of the study each patient must have a total of at least 2 new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions seen over the series of 3 pretreatment magnetic resonance imaging (MRI)s.

Exclusion Criteria

• Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
• Received any investigational drug or experimental procedure within 3 months prior to study day 0
• If the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows:

1. Cyclophosphamide or mitoxantrone- 6 months prior

2. Interferons, glatiramer acetate and azathioprine- 12 weeks prior

3. Methotrexate, IV immunoglobulin, cyclosporin, plasma exchange or corticosteroids- 8 weeks prior

• Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist
• Have an active infection or be considered to be at high risk for developing an infection
• Have a history of hepatitis B, C or human immunodeficiency virus (HIV)
• Have a chest X-ray within 6 months of study day 0 with clinically significant findings or abnormalities
• Have inadequate renal or hepatic function
• Have a known history of cancer, except for distant history (>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
• Received any live, attenuated vaccinations within 30 days prior to study day 0
• Have a history of illicit drug or alcohol abuse within 5 years of study day 0
• Have a history of hypersensitivity to prior monoclonal antibody (mAb) treatment
• Have a history of allergy or sensitivity to Gd
• Have a history that would preclude serial MRI scans

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Millennium Pharmaceuticals, Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Other Identifiers

MLN120204-063

Identifier Type: -

Identifier Source: org_study_id