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

Psoriasis Clinical Trial

— PHOENIX1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267969
• Other study ID #: CR006328
• Secondary ID: C0743T082005-003
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: June 10, 2013
• Start date: December 2005
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: Centocor Research & Development, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT01585714

Recruitment information / eligibility

• Status: Completed
• Enrollment: 766
• Est. completion date: May 2011
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor Research & Development, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12	No
Secondary	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].	Week 12	No
Secondary	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).	Baseline (Week 0), Week 12	No
Secondary	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.	Week 52	No