- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267969
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis (PHOENIX1)
June 10, 2013 updated by: Centocor Research & Development, Inc.
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
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.
Study Overview
Detailed Description
This is a randomized (patients are assigned to different treatments based on chance), double blind (neither the patient nor the physician knows whether medication or placebo [an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study] is being taken, or at what dosage), parallel-group (each group of patients are treated at the same time), multicenter study to determine the effectiveness and safety of two different doses of ustekinumab administered subcutaneously (under the skin) as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis).
766 patients will be randomized to Group 1 (ustekinumab 45 mg), Group 2 (ustekinumab 90 mg) and Group 3 (placebo) at Week 0. The study was designed to evaluate the effectiveness and safety of 2 dose regimens of ustekinumab: (1) 45 mg at Weeks 0 and 4 followed by 45 mg every 12 weeks maintenance therapy (treatment designed to help the original primary treatment succeed) and (2) 90 mg at Weeks 0 and 4 followed by 90 mg every 12 weeks maintenance therapy.
The study will consist of 4 periods: (1) Placebo-controlled portion of study [Week 0 to Week 12] during which the safety and effectiveness of 2 doses (45mg and 90mg) of ustekinumab will be compared to placebo; (2) Placebo crossover and active treatment portion of study [Week 12 to Week 40] during which patients randomized to receive placebo at Week 0 will crossover to receive ustekinumab, and all patients will receive active treatment; (3) Randomized withdrawal portion of study [beginning at Week 40] during which patients who received ustekinumab [45mg or 90mg every 12 weeks] at Week 0 and are responding to it, will be randomized either to placebo or continued maintenance therapy with ustekinumab; and (4) Long-term extension [from Week 52 to Week 264 (ie, 5 years)] period during which the safety and effectiveness of ustekinumab long-term use will be evaluated in patients.
Study Type
Interventional
Enrollment (Actual)
766
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussel, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Alberta
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Edmonton, Alberta, Canada
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New Brunswick
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Moncton, New Brunswick, Canada
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Newfoundland and Labrador
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St-John'S, Newfoundland and Labrador, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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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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Quebec
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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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Arizona
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Phoenix, Arizona, United States
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California
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Los Angeles, California, United States
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Redwood City, California, United States
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Santa Monica, California, United States
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Colorado
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Denver, Colorado, United States
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Delaware
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Wilmington, Delaware, United States
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Florida
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Ocala, Florida, United States
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Georgia
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Alpharetta, Georgia, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Hawaii
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Honolulu, Hawaii, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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Normal, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Louisiana
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Lake Charles, Louisiana, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Minnesota
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Fridley, Minnesota, United States
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Missouri
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Saint Louis, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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East Windsor, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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New York, New York, United States
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Oregon
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Tennessee
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Goodlettsville, Tennessee, United States
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Texas
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Dallas, Texas, United States
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Washington
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Seattle, Washington, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ustekinumab 45 mg
Patients 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.
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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.
Other Names:
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Experimental: ustekinumab 90 mg
Patients 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.
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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.
Other Names:
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Placebo Comparator: Placebo
Patients 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.
Time Frame: Week 12
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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.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Time Frame: Week 12
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The PGA is used to determine the participant's psoriasis lesions overall at a given time point.
Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling.
The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
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Week 12
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Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12
Time Frame: Baseline (Week 0), Week 12
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Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12.
This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
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Baseline (Week 0), Week 12
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Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52
Time Frame: Week 52
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The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 52 in participants randomly assigned to a treatment group at Week 40.
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.
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Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Centocor Research & Development, Inc. Clinical Trial, Centocor Research & Development, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Drug Saf. 2019 Apr 22;:
- Leonardi 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. Erratum In: Lancet. 2008 May 31;371(9627):1838.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
December 20, 2005
First Submitted That Met QC Criteria
December 20, 2005
First Posted (Estimate)
December 22, 2005
Study Record Updates
Last Update Posted (Estimate)
June 17, 2013
Last Update Submitted That Met QC Criteria
June 10, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR006328
- C0743T08 (Other Identifier: Centocor Research & Development, Inc., PA, USA)
- 2005-003529-15 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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