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

NCT ID: NCT00267969

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 766 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2011-05-31

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.

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

ustekinumab

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

ustekinumab

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

ustekinumab

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

Other Intervention Names

CNTO 1275

Eligibility Criteria

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)

• 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 Research & Development, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor Research & Development, Inc.

Locations

Phoenix, Arizona, United States

Los Angeles, California, United States

Redwood City, California, United States

Santa Monica, California, United States

Denver, Colorado, United States

Wilmington, Delaware, United States

Ocala, Florida, United States

Alpharetta, Georgia, United States

Marietta, Georgia, United States

Newnan, Georgia, United States

Honolulu, Hawaii, United States

Boise, Idaho, United States

Normal, Illinois, United States

Indianapolis, Indiana, United States

Lake Charles, Louisiana, United States

Worcester, Massachusetts, United States

Fridley, Minnesota, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

East Windsor, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Lake Oswego, Oregon, United States

Portland, Oregon, United States

Goodlettsville, Tennessee, United States

Dallas, Texas, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Brussels, , Belgium

Edegem, , Belgium

Edmonton, Alberta, Canada

Moncton, New Brunswick, Canada

St. John's, Newfoundland and Labrador, Canada

Halifax, Nova Scotia, 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

Countries

United States; Belgium; Canada

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)

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.

Reference Type: DERIVED

PMID: 18486739 (View on PubMed)

Other Identifiers

C0743T08

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003529-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR006328

Identifier Type: -

Identifier Source: org_study_id

NCT01585714

Identifier Type: -

Identifier Source: nct_alias