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
1780
mi
from 91732
Plainfield, ID
Click here to add this to my saved trials
1920
mi
from 91732
Alpharetta, GA
Click here to add this to my saved trials
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
2573
mi
from 91732
Andover, MA
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
1714
mi
from 91732
Arlington Heights, IL
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
106
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
1935
mi
from 91732
Bay City, MI
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
2200
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
1715
mi
from 91732
Evansville, IN
Click here to add this to my saved trials
?
mi
from 91732
Exton, PA
Click here to add this to my saved trials
207
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
1512
mi
from 91732
Fridley, MN
Click here to add this to my saved trials
2329
mi
from 91732
Hazleton, PA
Click here to add this to my saved trials
2141
mi
from 91732
High Point, NC
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
2558
mi
from 91732
Johnston, RI
Click here to add this to my saved trials
1994
mi
from 91732
Kingsport, TN
Click here to add this to my saved trials
1471
mi
from 91732
Lake Charles, LA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1813
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
2324
mi
from 91732
Miami Beach, FL
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2178
mi
from 91732
Ormond Bech, FL
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
1049
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
939
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
1573
mi
from 91732
St Louis, MO
Click here to add this to my saved trials
2503
mi
from 91732
Stony Brook, NY
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1964
mi
from 91732
Troy, MI
Click here to add this to my saved trials
2281
mi
from 91732
Washington,
Click here to add this to my saved trials
1376
mi
from 91732
Webster, TX
Click here to add this to my saved trials
1698
mi
from 91732
West Dundee, IL
Click here to add this to my saved trials