Clinical trial NCT01199640: Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
Official title: A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Each patient was to have met all of the following inclusion criteria to be enrolled in the study:

* 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:

Patients meeting any of the following exclusion criteria were not to be enrolled in the study:

* 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

Primary outcomes:
measure: To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS)
timeFrame: Day 61- Day 330
measure: To determine the efficacy of MLN1202 in patients with RRMS
timeFrame: Day 0- Day 180
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: