Clinical trial NCT00267969: A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Ustekinumab
CNTO1275
Plaque type Psoriasis
Interleukin-23
IL-23
Psoriasis
Interleukin 12
IL-12
Lead sponsor: Centocor Research & Development, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
timeFrame: Week 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12
timeFrame: Baseline (Week 0), Week 12
measure: Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Wilmington
country: United States
state: Delaware
city: Ocala
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Normal
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lake Charles
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: Fridley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: East Windsor
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Goodlettsville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Moncton
country: Canada
state: New Brunswick
city: St-John'S
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Centocor Research & Development, Inc.
name: Centocor Research & Development, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.