A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
NCT ID: NCT01090427
Last Updated: 2015-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2010-05-31
2014-01-31
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
QUADRUPLE
Study Groups
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Ustekinumab Half-standard Dosage
Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Ustekinumab - Half-Standard Dosage
Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.
Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Ustekinumab Standard Dosage
Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.
Ustekinumab - Standard Dosage
Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Placebo
Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.
Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Interventions
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Ustekinumab - Half-Standard Dosage
Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.
Ustekinumab - Standard Dosage
Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Eligibility Criteria
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Inclusion Criteria
* Are candidates for phototherapy or systemic treatment of psoriasis
* Have screening laboratory test results within the study parameters
Exclusion Criteria
* Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab
* Received conventional systemic therapies or phototherapy within the last 4 weeks
* Received biologic therapies within the last 3 months
12 Years
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Brussels, , Belgium
Ghent, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Moncton, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Bordeaux, , France
Nantes, , France
Nice, , France
Saint-Etienne, , France
Toulouse, , France
Berlin, , Germany
Dresden, , Germany
Erlangen, , Germany
Essen, , Germany
Hamburg, , Germany
Kiel, , Germany
Mainz, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Szeged, , Hungary
Braga, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Vila Nova de Gaia, , Portugal
Korolyov, , Russia
Krasnodar, , Russia
Moscow, , Russia
Rostov-on-Don, , Russia
Saratov, , Russia
Yekaterinburg, , Russia
Linköping, , Sweden
Stockholm, , Sweden
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Khmelnitskiy, , Ukraine
Kiev, , Ukraine
Simferopol, , Ukraine
Uzhhorod, , Ukraine
Zaporizhzhya, , Ukraine
Cardiff, , United Kingdom
London, , United Kingdom
York, , United Kingdom
Countries
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References
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Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.
Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.
Other Identifiers
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CNTO1275PSO3006
Identifier Type: OTHER
Identifier Source: secondary_id
CADMUS
Identifier Type: OTHER
Identifier Source: secondary_id
2009-014368-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR017053
Identifier Type: -
Identifier Source: org_study_id
NCT02166203
Identifier Type: -
Identifier Source: nct_alias
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