A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:March 2012
End Date:July 2015

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

A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

The purpose of the study is to assess the effect of extending maintenance dosing intervals
beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with
moderate-to-severe plaque psoriasis.

In this study, a proportion of subjects will receive study agent at its recommended dose and
interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than
100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will
have the opportunity to receive study agent less frequently during the randomization period
depending on the subject's response. The study consists of a 4-week screening period; a
28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104;
a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be
randomized for the double blind period into one of two study groups. Group 1 participants
will receive an injection of the study medication at a 12 week dosing interval. Group 2
participants will undergo a placebo withdrawal and may receive study agents at an extended
interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups
1 and 2 will receive placebo as necessary to maintain the blind.

Key Eligibility Criteria

- Male or female

- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first
administration of study agent (subjects with concurrent psoriatic arthritis may be
enrolled).

- Have plaque-type psoriasis covering at least 10% of their total BSA at screening and
at the time of the first administration of study agent.

- Have a PGA score of ≥ 3 at screening and at the time of the first administration of
study agent.
We found this trial at
40
sites
1260
mi
from 02139
Coral Gables, FL
Click here to add this to my saved trials
1569
mi
from 02139
Arlington, TX
Click here to add this to my saved trials
2587
mi
from 02139
Bakersfield, CA
Click here to add this to my saved trials
1048
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
2
mi
from 02139
Boston, MA
Click here to add this to my saved trials
135
mi
from 02139
Bridgeport, CT
Click here to add this to my saved trials
180
mi
from 02139
Bronx, NY
Click here to add this to my saved trials
846
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
527
mi
from 02139
Clarksburg, WV
Click here to add this to my saved trials
639
mi
from 02139
Columbus, OH
Click here to add this to my saved trials
1546
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
1763
mi
from 02139
Denver, CO
Click here to add this to my saved trials
229
mi
from 02139
East Windsor, NJ
Click here to add this to my saved trials
1118
mi
from 02139
Fridley, MN
Click here to add this to my saved trials
2362
mi
from 02139
Henderson, NV
Click here to add this to my saved trials
802
mi
from 02139
Indianapolis, IN
Click here to add this to my saved trials
2577
mi
from 02139
Irvine, CA
Click here to add this to my saved trials
42
mi
from 02139
Johnston, RI
Click here to add this to my saved trials
105
mi
from 02139
Lebanon, NH
Click here to add this to my saved trials
2588
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
821
mi
from 02139
Louisville, KY
Click here to add this to my saved trials
939
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
1356
mi
from 02139
New Orleans, LA
Click here to add this to my saved trials
180
mi
from 02139
New York, NY
Click here to add this to my saved trials
469
mi
from 02139
Norfolk, VA
Click here to add this to my saved trials
1494
mi
from 02139
Norman, OK
Click here to add this to my saved trials
479
mi
from 02139
Pittsburgh, PA
Click here to add this to my saved trials
816
mi
from 02139
Plainfield, IN
Click here to add this to my saved trials
2530
mi
from 02139
Portland, OR
Click here to add this to my saved trials
1033
mi
from 02139
Saint Louis, MO
Click here to add this to my saved trials
2091
mi
from 02139
Salt Lake City, UT
Click here to add this to my saved trials
2576
mi
from 02139
San Diego, CA
Click here to add this to my saved trials
2690
mi
from 02139
San Francisco, CA
Click here to add this to my saved trials
2601
mi
from 02139
Santa Monica, CA
Click here to add this to my saved trials
2256
mi
from 02139
Spokane, WA
Click here to add this to my saved trials
1037
mi
from 02139
St. Augustine, FL
Click here to add this to my saved trials
1182
mi
from 02139
Tampa, FL
Click here to add this to my saved trials
611
mi
from 02139
Troy, MI
Click here to add this to my saved trials
389
mi
from 02139
Williamsville, NY
Click here to add this to my saved trials
243
mi
from 02139
Yardley, PA
Click here to add this to my saved trials