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PsoriasisPhase 3PHOENIX1NCT00267969

A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis

A Phase 3 study testing ustekinumab in people with Psoriasis, run by Centocor Research & Development, Inc. at 42 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
766 participants
Where
42 sitesin 3 countries
Study dates
Dec 2005to May 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

42 sites in 3 countries.

42 sites in 3 countries

United States28 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alpharetta, Georgia

  • Study site

    Boise, Idaho

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    East Windsor, New Jersey

  • Study site

    Fridley, Minnesota

  • Study site

    Goodlettsville, Tennessee

  • Study site

    Honolulu, Hawaii

  • Study site

    Indianapolis, Indiana

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lake Oswego, Oregon

  • Study site

    Los Angeles, California

  • Study site

    Marietta, Georgia

  • Study site

    Milwaukee, Wisconsin

  • Study site

    New York, New York

  • Study site

    Newnan, Georgia

  • Study site

    Normal, Illinois

  • Study site

    Ocala, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Redwood City, California

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Wilmington, Delaware

  • Study site

    Worcester, Massachusetts

Other trials in United States

Canada12 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    London, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    North Bay, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Waterloo, Ontario

  • Study site

    Windsor, Ontario

Other trials in Canada

Belgium2 sites

  • Study site

    Brussels

  • Study site

    Edegem

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions
Psoriasis
Being tested
ustekinumab, placebo
Keywords
Ustekinumab, CNTO1275, Plaque type Psoriasis, Interleukin-23, IL-23, Psoriasis, Interleukin 12, IL-12
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ustekinumabDrug

    Also called CNTO 1275

    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.

  • placeboDrug

    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.

Study groups in NCT00267969
Study groupRoleWhat they receive
ustekinumab 45 mgExperimentalPatients 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.
Receives: Drug: ustekinumab
ustekinumab 90 mgExperimentalPatients 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.
Receives: Drug: ustekinumab
PlaceboPlacebo 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (3)

  1. Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

    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].

    Measured: Week 12

  2. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

    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).

    Measured: Baseline (Week 0), Week 12

  3. Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52

    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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionJul 2006
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00267969
Sponsor's protocol ID
CR006328
Other IDs
C0743T08, 2005-003529-15, 2005
Acronym
PHOENIX1
Status last verified
Jun 2013
First submitted
20 Dec 2005
Last updated
17 Jun 2013
Data monitoring committee
Yes

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.

    PubMed 30739254

  • 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.

    PubMed 18486739

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ustekinumab in people with Psoriasis, run by Centocor Research & Development, Inc. at 42 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00267969, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.

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