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PsoriasisPhase 3NCT00307437

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis

A Phase 3 study testing Ustekinumab (CNTO 1275) 45 mg and Ustekinumab (CNTO 1275) 90 mg in people with Psoriasis, run by Centocor Research & Development, Inc. at 62 sites in 7 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 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. 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 (CNTO 1275) 45 mg and Ustekinumab (CNTO 1275) 90 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,230 participants
Where
62 sitesin 7 countries
Study dates
May 2005to Oct 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

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

62 sites in 7 countries.

62 sites in 7 countries

United States28 sites

  • Study site

    Andover, Massachusetts

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Cleveland, Ohio

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Miami, Florida

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New York, New York

  • Study site

    Normal, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plymouth Meeting, Pennsylvania

  • Study site

    Port Huron, Michigan

  • Study site

    Portland, Oregon

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Skokie, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Canada16 sites

  • Study site

    Barrie, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • 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

    Surrey, British Columbia

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Waterloo, Ontario

  • Study site

    Windsor, Ontario

Other trials in Canada

Germany9 sites

  • Study site

    Berlin

  • Study site

    Brandenburg

  • Study site

    Dresden

  • Study site

    Erlangen

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Mainz

  • Study site

    München

Other trials in Germany

Austria3 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

United Kingdom3 sites

  • Study site

    London

  • Study site

    Salford

  • Study site

    Southampton Trials Carried Out

Other trials in United Kingdom

Switzerland2 sites

  • Study site

    Geneva

  • Study site

    Zurich

Other trials in Switzerland

France1 site

  • Study site

    Nice

Other trials in France

About this study

Official title: 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.

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.

Read the 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.

Conditions
Psoriasis
Being tested
Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg, Ustekinumab (CNTO 1275) 45 mg, Ustekinumab (CNTO 1275) 90 mg
Keywords
Moderate to Severe Plaque-Type Psoriasis, interleukin 23, IL-12, interleukin-12, interleukin-23, CNTO1275, biologic, Psoriasis, CNTO 1275, IL23, interleukin 12, IL-23, IL12, ustekinumab
Medical subject headings
Psoriasis

What participants receive

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

  • Placebo; Ustekinumab (CNTO 1275) 45 or 90 mgDrug

    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 (CNTO 1275) 45 mgDrug

    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 (CNTO 1275) 90 mgDrug

    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

Study groups in NCT00307437
Study groupRoleWhat they receive
Group I: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg
Group II: Ustekinumab 45 mgExperimentalNot described
Receives: Drug: Ustekinumab (CNTO 1275) 45 mg
Group III: Ustekinumab 90 mgExperimentalNot described
Receives: Drug: Ustekinumab (CNTO 1275) 90 mg

What is being measured

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

  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).

    Measured: Week 0 to Week 12

Secondary outcomes (3)

  1. Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12

    Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).

    Measured: Week 12

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

    Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The 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 to Week 12

  3. Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52

    Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. 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).

    Measured: Week 40 to 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 posted28 Mar 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionDec 2006
  4. Study completionOct 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307437
Sponsor's protocol ID
CR006325
Other IDs
C0743T09, 2005-003530-17, 2005
Status last verified
Jan 2013
First submitted
24 Mar 2006
Last updated
24 Jan 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

  • Papp 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.

    PubMed 18486740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab (CNTO 1275) 45 mg and Ustekinumab (CNTO 1275) 90 mg in people with Psoriasis, run by Centocor Research & Development, Inc. at 62 sites in 7 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 6 inclusion and 11 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada, Germany, Austria, United Kingdom and 2 more countries. 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 2 Nov 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?

Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (time frame: Week 0 to 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 NCT00307437, 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 24 Jan 2013.

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