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

NCT ID: NCT00307437

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2011-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg

Intervention Type: DRUG

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

Group II: Ustekinumab 45 mg

Group Type: EXPERIMENTAL

Ustekinumab (CNTO 1275) 45 mg

Intervention Type: DRUG

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

Group III: Ustekinumab 90 mg

Group Type: EXPERIMENTAL

Ustekinumab (CNTO 1275) 90 mg

Intervention Type: DRUG

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

Interventions

Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg

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

Intervention Type: DRUG

Ustekinumab (CNTO 1275) 45 mg

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

Intervention Type: DRUG

Ustekinumab (CNTO 1275) 90 mg

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Research & Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

La Jolla, California, United States

Los Angeles, California, United States

San Diego, California, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Normal, Illinois, United States

Skokie, Illinois, United States

Indianapolis, Indiana, United States

Louisville, Kentucky, United States

Andover, Massachusetts, United States

Boston, Massachusetts, United States

Port Huron, Michigan, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

New Brunswick, New Jersey, United States

New York, New York, United States

Winston-Salem, North Carolina, United States

Cleveland, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Plymouth Meeting, Pennsylvania, United States

Mt. Pleasant, South Carolina, United States

Nashville, Tennessee, United States

Houston, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Graz, , Austria

Innsbruck, , Austria

Vienna, , Austria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Moncton, New Brunswick, Canada

Halifax, Nova Scotia, Canada

Barrie, Ontario, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

North Bay, Ontario, Canada

Toronto, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Sherbrooke, Quebec, Canada

Nice, , France

Berlin, , Germany

Brandenburg, , Germany

Dresden, , Germany

Erlangen, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Kiel, , Germany

Mainz, , Germany

München, , Germany

Geneva, , Switzerland

Zurich, , Switzerland

London, , United Kingdom

Salford, , United Kingdom

Southampton Trials Carried Out, , United Kingdom

Countries

United States; Austria; Canada; France; Germany; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30739254 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18486740 (View on PubMed)

Other Identifiers

C0743T09

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003530-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR006325

Identifier Type: -

Identifier Source: org_study_id