Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 65
Updated:5/11/2018
Start Date:November 2013
End Date:December 2017

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A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
designed to evaluate the safety, tolerability and activity of ibudilast administered twice
daily over a 96 week period in subjects with primary or secondary progressive multiple
sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or
who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation
(IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be
administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive,
in two treatment groups. Randomization of subjects will be stratified by disease status
(primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and
immunomodulating therapy status: current use of immunomodulating therapy or no current use of
immunomodulating therapy.

The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96
weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase,
subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment
groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will
be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and
evening).


Inclusion Criteria:

- Written informed consent is obtained and willing and able to comply with the protocol
in the opinion of the Investigator.

- Male or female subjects ages 21 to 65, inclusive

- Confirmed diagnosis of SPMS or primary progressive multiple sclerosis (PPMS) according
to 2010 International Panel Criteria

- Typical MS lesions on MRI according to Swanton's MRI Criteria (at least one lesion in
two or more of the following regions: periventricular, juxtacortical, infratentorial
[brainstem/cerebellum], spinal cord)

- EDSS 3.0-6.5, inclusive

- Clinical evidence of disability progression in the preceding two years, as measured by
any of the following (excluding progression during clinical relapses):

- worsening overall EDSS of at least 0.5 points (may be assessed retrospectively
but cannot be during a clinical relapse) or

- 20% worsening in 25-foot walk (25-FW) or

- 20% worsening in 9-hole peg test (9-HPT) in either hand

- Existing multiple sclerosis pharmacotherapy status may include interferon-beta or
glatiramer acetate or none (i.e. untreated).

- Females of child-bearing potential must have a negative serum ß-hCG at screening and
must be willing to use appropriate contraception (as defined by the investigator) for
the duration of study treatment and 30 days after the last dose of study treatment.

- Males should practice contraception as follows: condom use and contraception by female
partner.

- Subject is in good physical health on the basis of medical history, physical
examination, and laboratory screening, as defined by the investigator.

- Subject is willing and able to comply with the protocol assessments and visits, in the
opinion of the study nurse/coordinator and the Investigator.

Exclusion Criteria:

- Progressive neurological disorder other than SPMS or PPMS

- Relapse and/or systemic corticosteroid steroid treatment for multiple sclerosis within
3 months of screening. Inhaled or topical steroids are allowed.

- Current use of intermittent systemic corticosteroids (i.e., monthly or bimonthly
intravenous methylprednisolone)

- Use of oral immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine,
teriflunomide [Aubagio®]) within 6 months of screening

- Use of mitoxantrone, natalizumab, or IVIg within 6 months of screening

- Use of fingolimod or dimethyl fumarate [Tecfidera®] within 3 months of screening

- Use of rituximab or other B-cell therapy within 12 months of screening

- Current use of other MS disease-modifying therapies (DMTs) besides glatiramer acetate,
IFNβ-1 (any formulation), and the above listed medications.

- Current use of cimetidine, cyclosporine, dronedarone, lopinavir, probenecid, quinidine
(including Neudexta), ranolazine, rifampin, ritonavir, or tipranavir.

- Clinically significant cardiovascular disease, including myocardial infarct within
last 6 months, unstable ischemic heart disease, congestive heart failure or angina

- Resting pulse < 50 bpm, sinoatrial (SA) or atrioventricular (AV) block, uncontrolled
hypertension, or QTcF > 450 ms

- Clinically significant pulmonary conditions, including severe chronic obstructive
pulmonary disease (COPD), fibrosis, or tuberculosis

- Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of
clinically significant impaired hepatic function through clinical and laboratory
evaluation including ALP > 1.5x ULN; ALT or AST > 2x ULN; GGT > 3x ULN

- Immune system disease (other than multiple sclerosis and autoimmune thyroid disease)

- History of stomach or intestinal surgery or any other condition that could interfere
with or is judged by the Investigator to interfere with absorption, distribution,
metabolism, or excretion of study drug.

- Any significant laboratory abnormality which, in the opinion of the Investigator, may
put the subject at risk and with the following laboratory abnormalities at screening:

- Creatinine: females > 0.95 mg/dL; males > 1.17 mg/dL

- WBCs < 3,000 mm3

- Lymphocytes < 800 mm3

- Platelets < 90,000 mm3

- History of malignancy < 5 years prior to signing the informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

- History of HIV (human immunodeficiency virus), clinically significant chronic
hepatitis, or other active infection.

- Subject currently has a clinically significant medical condition (other than MS)
including the following: neurological, psychiatric, metabolic, hepatic, renal,
hematological, pulmonary, cardiovascular (including uncontrolled hypertension),
gastrointestinal, urological disorder, or central nervous system (CNS) infection that
would pose a risk to the subject if they were to participate in the study or that
might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if,
in the judgment of the Investigator, they do not affect risk to the subject or the study
results. In cases in which the impact of the condition upon risk to the subject or study
results is unclear, the Medical Safety Monitor should be consulted.

- Subjects with moderate to severe depression as determined by the Beck Depression
Inventory-Fast Screen (BDI-FS).

- Subject has a history of alcohol or substance abuse (DSM-IV-TR criteria) within 3
months prior to screening or alcohol or substance dependence (DSM-IV-TR criteria)
within 12 months prior to screening. The only exceptions include caffeine or nicotine
abuse/dependence.

- Subject has poor peripheral venous access that will limit the ability to draw blood as
judged by the Investigator.

- Subject is currently participating, or has participated in, a study with an
investigational or marketed compound or device within 3 months prior to signing the
informed consent.

- Subject is unable to cooperate with any study procedures, unlikely to adhere to the
study procedures and keep appointments, in the opinion of the Investigator, or was
planning to relocate during the study.

- Subject is unable to undergo MRI imaging because of having an artificial heart valve,
metal plate, pin, or other metallic objects (including gun shots or shrapnel) in their
body or is unable to complete all the five MRI scans required for this study.
We found this trial at
28
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Charlottesville, Virginia
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Davis, California 95616
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Denver, Colorado 80291
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Evanston, Illinois 60208
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York 10021
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Seattle, Washington 98122
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