Study of Arimoclomol in Inclusion Body Myositis (IBM)



Status:Active, not recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:45 - Any
Updated:4/5/2019
Start Date:August 9, 2017
End Date:December 2021

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

Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM)

Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy
of the study drug, Arimoclomol in IBM patients.


Inclusion Criteria:

- Meet any of the European Neuromuscular Centre Inclusion Body Myositis research
diagnostic criteria 2011 categories for IBM

- Demonstrate being able to arise from a chair without support from another person or
device

- Able to ambulate at least 20 ft/6 meters with or without assistive device. Once arisen
from the chair, participant may use any walking device, i.e. walker/frame, can,
crutches, or braces. They cannot be supported by another person and cannot use
furniture or wall for support.

- Body weight of >= 40 kg

- Pre-menopausal women must have a negative pregnancy tst prior to dosing iwht study
medication.

- If a participant in the bimagrumab study, the participant must be off of the study
medication for at least 6 months.

- Able to give informed consent

Exclusion Criteria:

- History of any of the following excludes subject participation in the study: chronic
infection particularly HIV or Hepatitis B or C; cancer other than basal cell cancer
less than five years prior; or other chronic serious medical illnesses.

- Presence of any of the following on routine blood screening: WEB <3000; platelets <
100,000; hematocrit , 30%; BUN > 30 mg%; creatinine > 1.5 mg%; symptomatic liver
disease with serum albumin < 3 g/dL.

- History of most recent creatine kinase >15x the upper limit of normal without any
other explanation besides IBM.

- History of non-compliance with other therapies

- Use of testosterone except for physiologic replacement doses in case of androgen
deficiency. Participants must have documented proof of the androgen deficiency.

- Coexistence of other disease that would be likely to affect outcome measures.

- Drug or alcohol abuse within past three months

- Participation in a recent drug study in the last 30 days prior to the screening visit
or use of a biologic agent less than 6 months prior to the screening visit.

- Women who are lactating or unwilling to use adequate method of birth control who are
not surgically sterile. Adequate birth control includes use of intrauterine device,
abstinence, or oral contraceptives or a double barrier method, e.g condom plas
diaphragm will be necessary for both male and female participants.

- Participants taking >7.5 mg prednisolone or equivalent or participants on IVIg or
other immunosuppressants within the last 3 months.
We found this trial at
12
sites
Irvine, California 92697
949-824-5011
Principal Investigator: Tahseen Mozaffar, MD
Phone: 714-456-2864
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
?
mi
from
Irvine, CA
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Tom Lloyd, MD
Phone: 410-614-4188
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Anthony Amato, MD
Phone: 617-525-6763
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5090 N 40th St # 250
Phoenix, Arizona 85018
Principal Investigator: David Saperstein, MD
Phone: 602-258-2863
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Emma Ciafaloni, MD
Phone: 585-275-7867
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Summer Gibson, MD
Phone: 801-213-1018
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Matthew P. Wicklund, MD
Phone: 303-724-4644
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Ted Burns, MD
Phone: 434-924-5541
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Miriam Freimer, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Aziz Shaibani, MD
Phone: 713-795-0033
?
mi
from
Houston, TX
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Mazen Dimachkie, MD
Phone: 913-588-5095
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
London, WC1E 6BT
Principal Investigator: Pedro Machado, MD
Phone: 0203-108-7515
?
mi
from
London,
Click here to add this to my saved trials