Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 58
Updated:12/27/2018
Start Date:November 14, 2017
End Date:April 30, 2020

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

To evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks and
to evaluate the effects of BIIB033 versus placebo on additional measures of disability
improvement.


Key Inclusion Criteria:

- Baseline Expanded Disability Status Scale (EDSS) of 2.0 to 6.0, have a diagnosis of
relapsing-remitting multiple sclerosis (RRMS) per the 2010 McDonald's criteria or
onset of secondary progressive multiple sclerosis (SPMS) per the Lublin and Reingold
criteria, and should have experienced their first MS symptom(s) within the previous 20
years.

- Subjects must have experienced at least 1 of the following within 24 months prior to
Day 1/Baseline: a clinical relapse (but not within 24 weeks prior to Day 1/Baseline),
gadolinium-enhancing lesions on brain or spinal cord magnetic resonance imaging (MRI),
or new T2 lesion(s) on brain or spinal cord MRI.

- Subjects must be on a stable dose of a protocol-specified anti-inflammatory
disease-modifying therapy (DMT) (IFNβ [Avonex, Plegridy, Betaferon/Betaseron, or
Rebif], dimethyl fumarate (DMF) [Tecfidera], or natalizumab [Tysabri]) for at least 24
weeks prior to enrollment.

- In addition, subjects must have met protocol-defined MRI characteristics using
magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI) sequences at
Screening/Baseline.

Key Exclusion Criteria

- Primary progressive MS

- An MS relapse that has occurred within 24 weeks prior to Day 1/Baseline or the subject
has not stabilized from a previous relapse at the time of Screening.

- Treatment with any chemotherapeutic agents (e.g., mitoxantrone, cyclophosphamide,
cladribine), cell-depleting monoclonal antibodies (mAbs) (e.g., rituximab,
ocrelizumab, alemtuzumab), total lymphoid irradiation, T-cell or T-cell receptor
vaccination, or teriflunomide within 1 year prior to Day 1/Baseline.

- Treatment with other anti-inflammatory DMTs (e.g., GA, fingolimod, daclizumab) or
plasmapheresis within 24 weeks prior to Day1/Baseline.

- Treatment with Botox for limb spasticity within 24 weeks before Day 1/Baseline.

- Contraindications to MRI, for example, presence of pacemakers or other implanted metal
devices (excluding dental braces), an allergy to gadolinium renal impairment, or
claustrophobia that cannot be medically managed.

- History of human immunodeficiency virus or other immunodeficient conditions.

- History of malignancy; however, subjects with a history of excised or treated basal
cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in
this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
48
sites
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Berkeley, CA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Box Hill,
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Cullman, AL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Latham, NY
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lexington, MA
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Orem, UT
Click here to add this to my saved trials
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wellesley, MA
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials