A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/11/2018
Start Date:April 27, 2017
End Date:September 20, 2018

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A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab
for the treatment of participants with moderate to severe plaque-type psoriasis.

The study consists of Screening Phase(4 weeks before administration of study drug),Active
Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study
periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis
evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical
Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be
performed per the study procedures.The primary hypotheses are that guselkumab treatment is
non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90
response at Week 48 with noninferiority margin of 10% and,once non-inferiority is
established,that guselkumab is superior to secukinumab as assessed by proportion of
participants achieving PASI 90 response at Week 48.

Inclusion Criteria:

- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA)
for at least 6 months before the first administration of study drug

- A woman of childbearing potential must have a negative urine pregnancy test at
screening and at Week 0 and agree to urine pregnancy testing before receiving
injections

- Agree not to receive a live virus or live bacterial vaccination during the study, or
within 3 months after the last administration of study drug

- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or
within 12 months after the last administration of study drug

- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet light sources during study

Exclusion Criteria:

- Has a history or current signs or symptoms of severe, progressive, or uncontrolled
renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances

- Has previously received guselkumab or secukinumab

- Has a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection (example bronchiectasis), recurrent
urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin
wounds or ulcers

- Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive
of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access to veins
We found this trial at
45
sites
Santa Ana, California 92701
987
mi
from 98109
Santa Ana, CA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
2072
mi
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Birmingham, AL
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
2483
mi
from 98109
Ocala, FL
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1779
mi
from 98109
San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1779
mi
from 98109
San Antonio, TX
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Albuquerque, New Mexico 87106
1186
mi
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Albuquerque, NM
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Alpharetta, Georgia 30022
2173
mi
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Alpharetta, GA
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Atlanta, Georgia 30342
2174
mi
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Atlanta, GA
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Austin, Texas 78705
1770
mi
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Austin, TX
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Bay City, Michigan 48706
1858
mi
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Bay City, MI
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29 Carrara Street
Benowa, 4217
7372
mi
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Benowa,
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3555 Olentangy River Road
Bexley, Ohio 43214
2004
mi
from 98109
Bexley, OH
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Clearwater, Florida 33757
2511
mi
from 98109
Clearwater, FL
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Coral Gables, Florida 33134
2731
mi
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Coral Gables, FL
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Dallas, Texas 75231
1678
mi
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Dallas, TX
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1681
mi
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Dallas, TX
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Danbury, Connecticut 06810
2405
mi
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Danbury, CT
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Detroit, Michigan 48202
1930
mi
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Detroit, MI
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East Windsor, New Jersey 08520
2391
mi
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East Windsor, NJ
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Fort Gratiot, Michigan 48059
1939
mi
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Fort Gratiot, MI
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Fridley, Minnesota 55432
1389
mi
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Fridley, MN
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Gahanna, Ohio 43230
2010
mi
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Gahanna, OH
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High Point, North Carolina 27262
2290
mi
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High Point, NC
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1887
mi
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Houston, TX
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Indianapolis, Indiana 46256
1870
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Indianapolis, IN
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Johnston, Rhode Island 02919
2482
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Johnston, RI
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Los Angeles, California 90027
956
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Los Angeles, CA
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Louisville, Kentucky 40202
1939
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Louisville, KY
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2163
mi
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Marietta, GA
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Norfolk, Virginia 23507
2429
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Norfolk, VA
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Norman, Oklahoma 73069
1537
mi
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Norman, OK
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Oceanside, California 92056
1031
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Oceanside, CA
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Orange Park, Florida 32073
2456
mi
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Orange Park, FL
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2134
mi
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Pittsburgh, PA
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824 Edwards Drive
Plainfield, Indiana 46168
1860
mi
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Plainfield, IN
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Portland, Oregon 97210
146
mi
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Portland, OR
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Portland, Oregon 97223
153
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Portland, OR
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Rockville, Maryland 20850
2310
mi
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Rockville, MD
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5301 Keystone Court
Rolling Meadows, Illinois 60008
1710
mi
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Rolling Meadows, IL
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Saint Louis, Missouri 63117
1714
mi
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Saint Louis, MO
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San Diego, California 92103
1065
mi
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San Diego, CA
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15 Santa Rosa Street
San Luis Obispo, California 93405
856
mi
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San Luis Obispo, CA
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Seattle, Washington 98101
1
mi
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Seattle, WA
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9933 Woods Drive
Skokie, Illinois 60077
1721
mi
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Skokie, IL
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Troy, Michigan 48084
1920
mi
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Troy, MI
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