A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)
4 other identifiers
interventional
110
10 countries
50
Brief Summary
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
Typical duration for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
December 18, 2014
CompletedJanuary 29, 2015
January 1, 2015
2.7 years
March 18, 2010
December 10, 2014
January 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
Week 12
Secondary Outcomes (7)
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Week 12
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
Baseline; Week 12
The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
Week 12
The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
Week 12
The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
Week 12
- +2 more secondary outcomes
Study Arms (3)
Ustekinumab Half-standard Dosage
EXPERIMENTALParticipants 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 Standard Dosage
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Interventions
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 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months
- Are candidates for phototherapy or systemic treatment of psoriasis
- Have screening laboratory test results within the study parameters
You may not qualify if:
- Currently have nonplaque forms of psoriasis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
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Liège, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Bordeaux, France
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Nantes, France
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Nice, France
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Saint-Etienne, France
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Toulouse, France
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Berlin, Germany
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Dresden, Germany
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Erlangen, Germany
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Essen, Germany
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Hamburg, Germany
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Kiel, Germany
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Mainz, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Szeged, Hungary
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Braga, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Korolyov, Russia
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Krasnodar, Russia
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Moscow, Russia
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Rostov-on-Don, Russia
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Saratov, Russia
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Yekaterinburg, Russia
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Linköping, Sweden
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Stockholm, Sweden
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Dnipropetrovsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Khmelnitskiy, Ukraine
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Kiev, Ukraine
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Simferopol, Ukraine
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Uzhhorod, Ukraine
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Zaporizhzhya, Ukraine
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Cardiff, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
York, United Kingdom
Related Publications (2)
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.
PMID: 36171515DERIVEDLandells 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.
PMID: 26259989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VICE PRESIDENT IMMUNOLOGY
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 22, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2014
Last Updated
January 29, 2015
Results First Posted
December 18, 2014
Record last verified: 2015-01