Clinical trial NCT01090427: A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Ustekinumab
Injection
CNTO 1275
Stelara
Pediatric psoriasis
Adolescents
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Detailed description: This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Baseline; Week 12
measure: 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
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
timeFrame: Week 12
measure: The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
timeFrame: Week 12
measure: The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
timeFrame: Week 12
Other outcomes:
Locations:
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Bordeaux
country: France
city: Nantes
country: France
city: Nice
country: France
city: St Etienne
country: France
city: Toulouse Cedex 9
country: France
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Mainz
country: Germany
city: Budapest N/A
country: Hungary
city: Debrecen
country: Hungary
city: Szeged
country: Hungary
city: Braga
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Vila Nova De Gaia
country: Portugal
city: Ekaterinburg
country: Russian Federation
city: Korolev
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Rostov-On-Don
country: Russian Federation
city: Saratov
country: Russian Federation
city: Linköping
country: Sweden
city: Stockholm
country: Sweden
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Khmelnitskiy
country: Ukraine
city: Kiev
country: Ukraine
city: Simferopol
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Cardiff
country: United Kingdom
city: London
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.