A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
NCT ID: NCT01483599
Last Updated: 2017-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
293 participants
INTERVENTIONAL
2011-11-10
2013-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CNTO 1959 (5 mg)
CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
CNTO 1959 (5 mg)
Subcutaneous (SC) injections
CNTO 1959 (15 mg)
CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
CNTO 1959 (15 mg)
SC injections
CNTO 1959 (50 mg)
CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
CNTO 1959 (50 mg)
SC injections
CNTO 1959 (100 mg)
CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40
CNTO 1959 (100 mg)
SC injections
CNTO 1959 (200 mg)
CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40
CNTO 1959 (200 mg)
SC injections
Adalimumab (approved psoriasis dosing)
Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.)
Adalimumab
SC injections
Placebo to CNTO 1959 (100 mg)
Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
CNTO 1959 (100 mg)
SC injections
Placebo
SC injections
Interventions
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CNTO 1959 (5 mg)
Subcutaneous (SC) injections
CNTO 1959 (15 mg)
SC injections
CNTO 1959 (50 mg)
SC injections
CNTO 1959 (100 mg)
SC injections
CNTO 1959 (200 mg)
SC injections
Adalimumab
SC injections
Placebo
SC injections
Eligibility Criteria
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Inclusion Criteria
* Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
* Must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy
* If a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug
* If a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.
Exclusion Criteria
* Has a contra-indication to anti-TNF therapy
* Has a history of chronic or recurrent infectious disease
* Has a nonplaque form of psoriasis or has drug-induced psoriasis
* Has been previously treated with adalimumab
* Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab \[ABT-874\], AIN457, and SCH900222) within 6 months of the first administration of study agent.
18 Years
99 Years
ALL
No
Sponsors
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Janssen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Inc. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Inc.
Locations
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Birmingham, Alabama, United States
Bakersfield, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
Ocala, Florida, United States
Alpharetta, Georgia, United States
Arlington Heights, Illinois, United States
Skokie, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Andover, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Brussels, , Belgium
Ghent, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Moncton, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Hamburg, , Germany
Mahlow, , Germany
Münster, , Germany
Schwerin, , Germany
Gdansk, , Poland
Gmina Końskie, , Poland
Lodz, , Poland
Wroclaw, , Poland
Countries
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References
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Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
Gordon KB, Duffin KC, Bissonnette R, Prinz JC, Wasfi Y, Li S, Shen YK, Szapary P, Randazzo B, Reich K. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis. N Engl J Med. 2015 Jul 9;373(2):136-44. doi: 10.1056/NEJMoa1501646.
Other Identifiers
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CNTO1959PSO2001
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001066-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR100673
Identifier Type: -
Identifier Source: org_study_id
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