A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis
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.
3 other identifiers
interventional
1,230
7 countries
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2005
Longer than P75 for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
November 2, 2012
CompletedJanuary 24, 2013
January 1, 2013
1.6 years
March 24, 2006
October 23, 2009
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12
Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Week 0 to Week 12
Secondary Outcomes (3)
Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12
Week 12
Change in Dermatology Life Quality Index (DLQI) at Week 12
Baseline to Week 12
Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52
Week 40 to Week 52
Study Arms (3)
Group I: Placebo
PLACEBO COMPARATORGroup II: Ustekinumab 45 mg
EXPERIMENTALGroup III: Ustekinumab 90 mg
EXPERIMENTALInterventions
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
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
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
Eligibility Criteria
You may qualify if:
- Plaque-type psoriasis diagnosed \>= 6 months prior
- Plaque-type psoriasis covering at least 10% of total body surface areas
- Psoriasis area-and-severity index score of \>=12 at screening and baseline
- Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Women of childbearing potential and all men must agree to use adequate birth control measures throughout the trials and for 12 months following the last injection of study agent
- Have no history of latent or active tuberculosis (TB)
You may not qualify if:
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
- Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23
- Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
- Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months prior to screening
- Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
- Patients participating in another trial using an investigational agent or procedure
- Systemic immunosuppressants within 4 weeks of the first administration of study agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Normal, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Andover, Massachusetts, United States
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Boston, Massachusetts, United States
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Port Huron, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Plymouth Meeting, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Graz, Austria
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Innsbruck, Austria
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Vienna, Austria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Nice, France
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Berlin, Germany
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Brandenburg, Germany
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Dresden, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Kiel, Germany
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Mainz, Germany
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München, Germany
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Geneva, Switzerland
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Zurich, Switzerland
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London, United Kingdom
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Salford, United Kingdom
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Southampton Trials Carried Out, United Kingdom
Related Publications (2)
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
PMID: 30739254DERIVEDPapp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17;371(9625):1675-84. doi: 10.1016/S0140-6736(08)60726-6.
PMID: 18486740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The count of patients with any nonserious adverse event (NAE) excludes patients who only had NAE that occured in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirements of this website.
Results Point of Contact
- Title
- Senior Director, Compound Development Team Leader
- Organization
- Centocor Research & Development, Inc.
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2006
First Posted
March 28, 2006
Study Start
May 1, 2005
Primary Completion
December 1, 2006
Study Completion
October 1, 2011
Last Updated
January 24, 2013
Results First Posted
November 2, 2012
Record last verified: 2013-01