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):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01090427
First received: March 18, 2010
Last updated: January 24, 2014
Last verified: January 2014
  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
Biological: ustekinumab/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 Centocor, Inc.:

Primary Outcome Measures:
  • Proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared or minimal disease [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients that achieve Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2010
Study Completion Date: November 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
ustekinumab/placebo Low dose (0.375 mg/kg for <60 kg or fixed doses of 22.5 mg or 45mg based on weight) at Weeks 0 and 4 then every 12 Weeks through Week 40. Patients will receive a single dose of placebo at Week 12
Biological: ustekinumab/placebo
Low dose (0.375 mg/kg for <60 kg
Experimental: 002
ustekinumab/placebo High Dose (0.75mg/kg for < 60 kg or fixed doses of 45mg or 90 mg based on weight) at Weeks 0 and 4 then every 12 Weeks through Week 40. Patients will receive a single dose of placebo at Week 12.
Biological: ustekinumab/placebo
or fixed doses of 22.5 mg or 45mg based on weight) at Weeks 0 and 4 then every 12 Weeks through Week 40. Patients will receive a single dose of placebo at Week 12
Experimental: 003
ustekinumab/placebo Patients will receive placebo at Weeks 0 and 4. Based on weight patient will then receive either ustekinumab low dose or high dose at Weeks 12 16 and every 12 weeks through Week 40
Biological: ustekinumab/placebo
High Dose (0.75mg/kg for < 60 kg

Detailed Description:

Ustekinumab is a drug that is being tested to see if it may be useful in treating adolescents with moderate to severe plaque-type psoriasis. This study will compare the effects (both good and bad) of ustekinumab to those of placebo. Placebo looks like the drug being studied but has no active ingredients. Ustekinumab (also known as Stelara) has been approved by the Food and Drug Administration, Health Canada, European and other global regulatory authorities for the treatment of patients with moderate to severe plaque-type psoriasis. Ustekinumab is being studied in several other illnesses. About 150 adolescents will take part in the study. Each patient who is allowed to join the study is put into a group by chance (randomly). There are 4 treatment groups in this study: GROUP 1: Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 2: Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 3a : Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28 & 40. GROUP 3b: Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 & 40. For dose description, please refer to Treatment Arm Section. Each patient will either receive ustekinumab or placebo, at the start of the study. By week 12 everyone will be receiving Ustekinumab. The dose of medication the patient will receive is based on his/her assigned group and the patient's weight. There are 2 dose groups - low dose and high dose. So that no one knows which dose any patient is receiving at one time - 2 injections will be given to each patient at each injection visit. While the study is ongoing, neither the patient nor the study doctor (or his/her staff) will know which treatment group the patient is in. Patients will be in the study approximately 60 weeks. Clinical safety will be assessed by the incidence and severity of adverse events, clinical laboratory tests, vital signs and physical examinations during the study period. There are 4 treatment groups in this study. Group 1 will receive Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections at week 12. Group 2: Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections at week 12. Group 3a: Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28 & 40 and GROUP 3b: Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 & 40.

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

  Show 50 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01090427     History of Changes
Other Study ID Numbers: CR017053, CNTO1275PSO3006, CADMUS, 2009-014368-20
Study First Received: March 18, 2010
Last Updated: January 24, 2014
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
United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Ustekinumab
Injection
CNTO 1275
Stelara
Pediatric psoriasis
Adolescents

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014