NCT01090427.

Trial name or title	A study of the safety and efficacy of ustekinumab in adolescent patients with psoriasis (CADMUS)
Methods	This is a phase 3 multicentre, randomised, double‐blind, placebo‐controlled study evaluating the of efficacy and safety of ustekinumab in the treatment of adolescent participants with moderate to severe plaque‐type psoriasis (CADMUS)
Participants	People from 12 to 18 years of age with a diagnosis of plaque‐type psoriasis with or without psoriatic arthritis for at least 6 months and who are candidates for phototherapy or systemic treatment of psoriasis and who have screening laboratory test results within the study parameters. Exclusion criteria are: people with non‐plaque forms of psoriasis or who have used any therapeutic agent targeted at reducing interleukin‐12 or interleukin‐23, including but not limited to ustekinumab and briakinumab; who received conventional systemic therapies or phototherapy within the last 4 weeks or who received biologic therapies within the last 3 months
Interventions	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). In addition, all participants will receive a single subcutaneous 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). In addition, all participants will receive a single subcutaneous dose of placebo at week 12 Placebo administered subcutaneously at weeks 0 and 4 or at week 12
Outcomes	Primary outcome: proportion of participants who achieve a PGA score of cleared or minimal disease at week 12 Secondary outcome measures: proportion of participants who achieve a PASI 90 response, proportion of participants who achieve PASI 75 response, and the change from baseline in CDLQI at week 12
Starting date	May 2010
Contact information	Study director: Janssen Research & Development, LLC Clinical Trial. Janssen Research & Development, LLC
Notes	This study is sponsored by Janssen Research & Development, LLC. The results are posted at www.clinicaltrials.gov (www.clinicaltrials.gov/ct2/show/results/NCT01090427). Last access date: 9 July 2015