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

NCT01199640 | Completed Phase 2

• 1 other identifier: MLN120204-063
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS)

  Vital sign measurement, physical examinations, multiple sclerosis (MS) relapses, changes in expanded disability status scale (EDSS) scores and standard laboratory test results, as well as the incidence of adverse events and serious adverse events

  Day 61- Day 330

• To determine the efficacy of MLN1202 in patients with RRMS

  Comparing the mean number of new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions on magnetic resonance imaging (MRI) scans during the pretreatment phase with the mean number of new Gd-enhancing lesions found during the treatment phase

  Day 0- Day 180

Study Arms (1)

MLN1202

EXPERIMENTAL

Drug: MLN1202

Interventions

MLN1202 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).

MLN1202

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Cyclophosphamide or mitoxantrone- 6 months prior
• Interferons, glatiramer acetate and azathioprine- 12 weeks prior
• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

plozalizumab

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

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: May 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 13, 2010

Record last verified: 2010-09