Intravenously Administered Study Medication MEDI-545, in Adults
with Dermatomyositis (DM) or Polymyositis (PM)
Trial Status
Open for Enrollment
What is the Purpose of this Research Study?
To evaluate the safety and tolerability of multiple intravenous (IV) doses
of MEDI-545, an investigational drug, in adults with DM or PM
who have a high level of expression of mRNA for type I IFN-inducible
genes at time of randomization.
Who is Eligible to Participate?
Individuals 18 years and older with probable of definite DM or PM diagnosis.
For people with PM, a previous muscle biopsy result that is consistent
with the diagnosis is required. Individuals with both PM and DM will
also have to meet other inclusion criteria and do not meet any exclusionary
criteria which will be addressed in further detail by study coordinator
What is involved in this Study?
Qualified participants
will be randomized (like flipping a coin) in a 3:1 ratio to initially receive
MEDI-545 (1.0, 3.0, 10.0 or 30.0 mg/kg) or placebo (an inactive substance)
every 2 weeks for 12 weeks for a total of 7 doses. Thereafter (2 weeks later),
in each dose cohort, participants randomized to MEDI-545, will continue to
receive the same dose over an additional 12 weeks (7 doses) and participants
randomized to placebo will receive MEDI-545 at the dose specified in the dose
cohort, every 2 weeks for an additional 12 weeks (7doses) for a total of 26
weeks (14 doses).
How long is the Study?
The study is approximately 1 year long, with 26 weeks of study-treatment.
For More Information Contact: Lynne E. Flynn, CCRC, study coordinator,
at 602-258-2863 or lynneflynn@pnal.net or call the Main line at 602-258-3354
or call the Main line at 602-258-3354
Dermatomyositis Symptoms
Causes of Dermatomyositis
Cure for Dermatomyositis
Dermatomyositis Treatment
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