A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:December 2012
End Date:July 2019
Contact:Toll Free Number
Phone:1-888-577-8839

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

A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous SCH 900222/MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

This study is being conducted to evaluate the efficacy and safety/tolerability of
subcutaneous MK-3222, followed by an optional long-term safety

extension study, in participants with moderate-to-severe chronic plaque psoriasis.


Inclusion Criteria:

- Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior
to study enrollment

- A candidate for phototherapy or systemic therapy

- For the extension study: must have completed Part 3 of the base study

- For the extension study: must have achieved at least a PASI-50 response by the end of
Part 3 of the base study

- For the extension study: must have received active MK-3222 treatment within 12 weeks
prior to the end of Part 3 of the base study

- Premenopausal female participants must agree to abstain from heterosexual activity or
use a medically accepted method of contraception or use appropriate effective
contraception as per local regulations or guidelines

- If enrolled at a Japanese site, participants with psoriatic arthritis using
non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least
4 weeks prior to the first dose of study drug and must not be expected to require an
increase in dose over the course of the study

Exclusion Criteria:

- Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or
medication-exacerbated psoriasis, or new onset guttate psoriasis

- Current or history of severe psoriatic arthritis and is well-controlled on current
treatment

- Women of child-bearing potential that are pregnant, intend to become pregnant within
6 months of completing the trial, or that are breast feeding

- Expected to require topical treatment, phototherapy, or systemic treatment during the
trial

- Presence of any infection

- History of recurrent infection requiring treatment with systemic antibiotics within 2
weeks of screening

- Previous use of MK-3222 or other IL-23/Th-17 pathway inhibitors including P40, p19,
and IL-17 antagonists

- Evidence of active or untreated latent tuberculosis (TB)

- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBs Ag) or hepatitis C virus (HCV)

- At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV)
deoxyribonucleic acid (DNA)

- At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA

- For the extension study: women of child-bearing potential that are pregnant, intend
to become pregnant within 6 months of completing the trial, or that are breast
feeding

- For the extension study: active or uncontrolled significant organ dysfunction or
clinically significant laboratory abnormalities

- For the extension study: expected to require topical treatment, phototherapy, or
systemic treatment during the extension study

- At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the
screening visit.
We found this trial at
44
sites
1383
mi
from
Portland, OR
Click here to add this to my saved trials
797
mi
from
Alpharetta, GA
Click here to add this to my saved trials
1157
mi
from
Anaheim, CA
Click here to add this to my saved trials
1441
mi
from
Andover, MA
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
601
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
1184
mi
from
Bakersfield, CA
Click here to add this to my saved trials
832
mi
from
Bay City, MI
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
1052
mi
from
Duncansville, PA
Click here to add this to my saved trials
559
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Exton, PA
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
558
mi
from
Fridley, MN
Click here to add this to my saved trials
1184
mi
from
Hazleton, PA
Click here to add this to my saved trials
991
mi
from
High Point, NC
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1419
mi
from
Johnston, RI
Click here to add this to my saved trials
843
mi
from
Kingsport, TN
Click here to add this to my saved trials
583
mi
from
Lake Charles, LA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
657
mi
from
Louisville, KY
Click here to add this to my saved trials
1323
mi
from
Miami Beach, FL
Click here to add this to my saved trials
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
262
mi
from
Omaha, NE
Click here to add this to my saved trials
1119
mi
from
Ormond Bech, FL
Click here to add this to my saved trials
630
mi
from
Plainfield, ID
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
520
mi
from
Rapid City, SD
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
1201
mi
from
Spokane, WA
Click here to add this to my saved trials
418
mi
from
St Louis, MO
Click here to add this to my saved trials
1358
mi
from
Stony Brook, NY
Click here to add this to my saved trials
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
843
mi
from
Troy, MI
Click here to add this to my saved trials
1127
mi
from
Washington,
Click here to add this to my saved trials
587
mi
from
Webster, TX
Click here to add this to my saved trials
587
mi
from
West Dundee, IL
Click here to add this to my saved trials