A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

Last updated: October 1, 2014
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Rosacea

Warts

Treatment

N/A

Clinical Study ID

NCT02166203
CR017053
CNTO1275PSO3006
CADMUS
2009-014368-20
  • Ages 12-18
  • Both

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Currently have nonplaque forms of psoriasis

  • Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) orinterleukin-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

Study Design

Total Participants: 110
Study Start date:
May 01, 2010
Estimated Completion Date:
January 31, 2014

Study 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.

Connect with a study center

  • Brussel,
    Belgium

    Site Not Available

  • Gent,
    Belgium

    Site Not Available

  • Liege,
    Belgium

    Site Not Available

  • Calgary, Alberta
    Canada

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Moncton, New Brunswick
    Canada

    Site Not Available

  • St. John'S, Newfoundland and Labrador
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • Kitchener, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Bordeaux,
    France

    Site Not Available

  • Nantes,
    France

    Site Not Available

  • Nice,
    France

    Site Not Available

  • St Etienne,
    France

    Site Not Available

  • Toulouse Cedex 9,
    France

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Dresden,
    Germany

    Site Not Available

  • Erlangen,
    Germany

    Site Not Available

  • Essen,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Kiel,
    Germany

    Site Not Available

  • Mainz,
    Germany

    Site Not Available

  • Budapest N/A,
    Hungary

    Site Not Available

  • Debrecen,
    Hungary

    Site Not Available

  • Szeged,
    Hungary

    Site Not Available

  • Braga,
    Portugal

    Site Not Available

  • Lisboa,
    Portugal

    Site Not Available

  • Porto,
    Portugal

    Site Not Available

  • Vila Nova De Gaia,
    Portugal

    Site Not Available

  • Ekaterinburg,
    Russian Federation

    Site Not Available

  • Korolev,
    Russian Federation

    Site Not Available

  • Krasnodar,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Rostov-On-Don,
    Russian Federation

    Site Not Available

  • Saratov,
    Russian Federation

    Site Not Available

  • Linköping,
    Sweden

    Site Not Available

  • Stockholm,
    Sweden

    Site Not Available

  • Dnipropetrovsk,
    Ukraine

    Site Not Available

  • Ivano-Frankivsk,
    Ukraine

    Site Not Available

  • Khmelnitskiy,
    Ukraine

    Site Not Available

  • Kiev,
    Ukraine

    Site Not Available

  • Simferopol,
    Ukraine

    Site Not Available

  • Uzhgorod,
    Ukraine

    Site Not Available

  • Zaporozhye,
    Ukraine

    Site Not Available

  • Cardiff,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • York,
    United Kingdom

    Site Not Available

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