Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

PHASE2CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

March 19, 2014

Primary Completion Date

December 7, 2017

Study Completion Date

March 1, 2018

Conditions
Psoriasis
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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"

DRUG

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.

DRUG

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.

Trial Locations (10)

10065

The Rockefeller University, New York

27104

Wake Forest University, Winston-Salem

44106

Case Western University, Cleveland

48109

University of Michigan, Ann Arbor

60611

Northwestern University, Chicago

70112

Tulane University School of Medicine: Dept. of Dermatology, New Orleans

84132

The University of Utah, Salt Lake City

90045

Dermatology Research Associates, Los Angeles

T2G 1B1

Kirk Barber Research, Calgary

H2K 4L5

Innovaderm Research Inc., Montreal

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01999868 - Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris | Biotech Hunter | Biotech Hunter