108
Participants
Start Date
March 19, 2014
Primary Completion Date
December 7, 2017
Study Completion Date
March 1, 2018
Ustekinumab
"Ustekinumab interferes with the actions of proteins, interleukin 12 (IL12) and interleukin 23 (IL23), which reduces inflammation (swelling) in the skin. Stelara™ is the trade name for ustekinumab and is approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis.~Dose:~Participants who weigh \<= 100 kg at study entry will receive 45 mg of ustekinumab.~Participants who weigh \> 100 kg at study entry will receive 90 mg of ustekinumab."
Abatacept
"Abatacept (one form of the protein called CTLA4-Ig) interacts with the immune system, reducing the activity of T-cells and may prevent relapse. Orencia™ is the trade name for abatacept, and it is approved by the FDA to treat rheumatoid arthritis in adults.~Dose:~125 mg sub-cutaneous injection"
UST Placebo
The abatacept treatment group will also receive subcutaneous placebo for ustekinumab (sterile normal saline) at week 16 and week 28, corresponding to the ustekinumab dosing regimen.
ABA Placebo
The ustekinumab treatment group will also receive weekly subcutaneous injections of placebo for abatacept from week 12 to week 39, corresponding to the abatacept dosing regimen.
The Rockefeller University, New York
Wake Forest University, Winston-Salem
Case Western University, Cleveland
University of Michigan, Ann Arbor
Northwestern University, Chicago
Tulane University School of Medicine: Dept. of Dermatology, New Orleans
The University of Utah, Salt Lake City
Dermatology Research Associates, Los Angeles
Kirk Barber Research, Calgary
Innovaderm Research Inc., Montreal
Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH