A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
PHOENIX1
A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
3 other identifiers
interventional
766
3 countries
42
Brief Summary
The primary purpose of this study is to evaluate the effectiveness 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 Dec 2005
Longer than P75 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 20, 2005
CompletedFirst Posted
Study publicly available on registry
December 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
August 24, 2012
CompletedJune 17, 2013
June 1, 2013
7 months
December 20, 2005
October 23, 2009
June 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.
The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Week 12
Secondary Outcomes (3)
Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12
Baseline (Week 0), Week 12
Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52
Week 52
Study Arms (3)
ustekinumab 45 mg
EXPERIMENTALPatients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
ustekinumab 90 mg
EXPERIMENTALPatients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
Placebo
PLACEBO COMPARATORPatients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
Interventions
Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.
Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.
Eligibility Criteria
You may qualify if:
- Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at least 10% of total body surface areas
- Have psoriasis area-and-severity index score of \>=12
- Patients who are considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Have no history of latent or active TB
You may not qualify if:
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Have any therapeutic agent targeted at reducing IL-12 or IL-23
- Have had a BCG vaccination within the previous 12 months
- 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
- Have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Redwood City, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Wilmington, Delaware, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Alpharetta, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Newnan, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Normal, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Fridley, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
East Windsor, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Lake Oswego, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Goodlettsville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Edegem, Belgium
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Moncton, New Brunswick, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
North Bay, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Waterloo, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Sainte-Foy, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
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: 30739254DERIVEDLeonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y, Li S, Dooley LT, Gordon KB; PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008 May 17;371(9625):1665-74. doi: 10.1016/S0140-6736(08)60725-4.
PMID: 18486739DERIVED
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
- Dir. Clinical Research
- Organization
- Centocor Research & Development, Inc.
Study Officials
- STUDY DIRECTOR
Centocor Research & Development, Inc. Clinical Trial
Centocor Research & Development, 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2005
First Posted
December 22, 2005
Study Start
December 1, 2005
Primary Completion
July 1, 2006
Study Completion
May 1, 2011
Last Updated
June 17, 2013
Results First Posted
August 24, 2012
Record last verified: 2013-06