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
Dallas, Texas 75231
905
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Dallas, TX
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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...
493
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Birmingham, AL
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
746
mi
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Ocala, FL
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1137
mi
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San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1137
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San Antonio, TX
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Albuquerque, New Mexico 87106
1331
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Alpharetta, Georgia 30022
415
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Alpharetta, GA
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Atlanta, Georgia 30342
426
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Atlanta, GA
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Austin, Texas 78705
1065
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Austin, TX
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Bay City, Michigan 48706
255
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Bay City, MI
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29 Carrara Street
Benowa, 4217
9156
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Benowa,
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3555 Olentangy River Road
Bexley, Ohio 43214
4
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Bexley, OH
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Clearwater, Florida 33757
829
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Clearwater, FL
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Coral Gables, Florida 33134
996
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Coral Gables, FL
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911
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Dallas, TX
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Danbury, Connecticut 06810
510
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Detroit, Michigan 48202
166
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East Windsor, New Jersey 08520
448
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East Windsor, NJ
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Fort Gratiot, Michigan 48059
214
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Fort Gratiot, MI
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Fridley, Minnesota 55432
629
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Gahanna, Ohio 43230
8
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High Point, North Carolina 27262
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High Point, NC
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Houston, TX
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Johnston, Rhode Island 02919
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Johnston, RI
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Los Angeles, California 90027
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Louisville, Kentucky 40202
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Louisville, KY
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423
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Marietta, GA
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Norfolk, Virginia 23507
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Norfolk, VA
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Norman, Oklahoma 73069
853
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Norman, OK
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Oceanside, California 92056
1945
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Orange Park, Florida 32073
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164
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Pittsburgh, PA
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824 Edwards Drive
Plainfield, Indiana 46168
178
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Plainfield, IN
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Portland, Oregon 97210
2028
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Portland, OR
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Portland, Oregon 97223
2032
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Portland, OR
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Rockville, Maryland 20850
318
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Rockville, MD
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5301 Keystone Court
Rolling Meadows, Illinois 60008
297
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Saint Louis, Missouri 63117
401
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San Diego, California 92103
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15 Santa Rosa Street
San Luis Obispo, California 93405
2069
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Santa Ana, California 92701
1960
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Seattle, Washington 98101
2007
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9933 Woods Drive
Skokie, Illinois 60077
286
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Skokie, IL
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Troy, Michigan 48084
179
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Troy, MI
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