Download A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in
Patients With Moderate to Severe Psoriasis
Status: Completed
Study Phase: Phase 3
Start Date: May 2005 | Completion Date: October 2011
Condition(s): Psoriasis
Full Title of Study
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating
the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to
Severe Plaque-type Psoriasis.
Overview
The primary objective of this study is to evaluate the efficacy and safety of
ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe
plaque psoriasis.
Detailed Description
Although numerous therapeutic options exist for the treatment of psoriasis, there is
still a significant unmet medical need due to the limited effectiveness and/or
significant side effect profile of current treatment options. Preclinical studies and
early phase clinical studies suggest that interleukins-12 and -23, two molecules that
are part of the communication network in the immune system, may play an
important role in psoriasis. Ustekinumab (CNTO 1275) is a monoclonal antibody
directed against interleukins -12 and -23. This is a randomized (study drug assigned
by chance like flipping a coin), double blind (neither physician nor patient knows the
name of the assigned drug), parallel-group, multicenter study to determine the
effectiveness and safety of two different doses of ustekinumab (CNTO 1275)
administered subcutaneously (under the skin) as compared with placebo in patients
with moderate to severe plaque-type psoriasis (the most common type of psoriasis).
The hypothesis is that ustekinumab (CNTO 1275) will be more effective in treatment
of psoriasis than placebo, that the improvement in psoriasis will result in an improved
quality of life for treated patients and that ustekinumab (CNTO 1275) will be generally
well tolerated. Patients will receive ustekinumab (CNTO 1275), 45 or 90 mg, or
placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks
thereafter until week 52. For patients who partially respond to the starting regimen,
the dosing interval may be adjusted to every 8 weeks. Patients will enter long term
extension portion of the study at week 52 during which patients will continue to
receive treatment with ustekinumab (CNTO 1275) and will be followed for a total of
up to 264 weeks from the initial (week 0) administration of study agent. The dose of
ustekinumab (CNTO 1275) will be 45 or 90 mg or placebo administered
subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For patients
who partially respond to the starting regimen, the dosing interval may be adjusted to
every 8 weeks.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Centocor Research & Development, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Trial Location Details
Facility: Birmingham, United States
Facility: Little Rock, United States
Facility: La Jolla, United States
Facility: Los Angeles, United States
Facility: San Diego, United States
Facility: Jacksonville, United States
Facility: Miami, United States
Facility: Normal, United States
Facility: Skokie, United States
Facility: Indianapolis, United States
Facility: Louisville, United States
Facility: Andover, United States
Facility: Boston, United States
Facility: Port Huron, United States
Facility: Saint Louis, United States
Facility: Las Vegas, United States
Facility: New Brunswick, United States
Facility: New York, United States
Facility: Winston Salem, United States
Facility: Cleveland, United States
Facility: Portland, United States
Facility: Philadelphia, United States
Facility: Plymouth Meeting, United States
Facility: Mt. Pleasant, United States
Facility: Nashville, United States
Facility: Houston, United States
Facility: San Antonio, United States
Facility: Salt Lake City, United States
Facility: Graz, Austria
Facility: Innsbruck, Austria
Facility: Wien, Austria
Facility: Calgary, Canada
Facility: Edmonton, Canada
Facility: Surrey, Canada
Facility: Vancouver, Canada
Facility: Moncton, Canada
Facility: Halifax, Canada
Facility: Barrie, Canada
Facility: Hamilton, Canada
Facility: London, Canada
Facility: North Bay, Canada
Facility: Toronto, Canada
Facility: Waterloo, Canada
Facility: Windsor, Canada
Facility: Montreal, Canada
Facility: Sainte-Foy, Canada
Facility: Sherbrooke, Canada
Facility: Nice, France
Facility: Berlin, Germany
Facility: Brandenburg, Germany
Facility: Dresden, Germany
Facility: Erlangen, Germany
Facility: Frankfurt, Germany
Facility: Hamburg, Germany
Facility: Kiel, Germany
Facility: Mainz, Germany
Facility: Munchen, Germany
Facility: Genève, Switzerland
Facility: Zurich N/A, Switzerland
Facility: London, United Kingdom
Facility: Salford, United Kingdom
Facility: Southampton Trials Carried Out, United Kingdom
Interventions
Drug: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg
Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen
to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the
investigator's discretion for Weeks 52 to 264
Drug: Ustekinumab (CNTO 1275) 45 mg
Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by
patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for
Weeks 52 to 264
Drug: Ustekinumab (CNTO 1275) 90 mg
Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by
patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for
Weeks 52 to 264
Information Source
ID Number: CR006325
NCT Identifier: NCT00307437
Health Authority: United States: Food and Drug Administration
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00307437
ClinicalTrials.gov processed this data on October 12, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.