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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01090427
First received: March 18, 2010
Last updated: January 16, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: Ustekinumab - Half-Standard Dosage
Drug: Ustekinumab - Standard Dosage
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.

  • 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 [ Time Frame: Baseline; Week 12 ] [ Designated as safety issue: No ]
    The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.

  • 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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.

  • 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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.

  • The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.

  • 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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.

  • The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other: Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Experimental: 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.
Drug: 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.
Other: Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Experimental: 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.
Other: Placebo
Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090427

  Show 50 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01090427     History of Changes
Obsolete Identifiers: NCT02166203
Other Study ID Numbers: CR017053, CNTO1275PSO3006, CADMUS, 2009-014368-20
Study First Received: March 18, 2010
Results First Received: December 10, 2014
Last Updated: January 16, 2015
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
Germany: Ethics Commission
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health
Germany: Paul-Ehrlich-Institut
Russia: Ethics Committee

Keywords provided by Janssen Research & Development, LLC:
Ustekinumab
Injection
CNTO 1275
Stelara
Pediatric psoriasis
Adolescents

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 05, 2015