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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Detailed Description
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This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Official Title
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A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Ustekinumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a diagnosis of plaque-type psoriasis at least 6 months Plaque-type psoriasis covering at least 10% of total body surface areas Psoriasis area-and-severity index score of 12 or greater 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 Have no history of latent or active tuberculosis 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 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 Patients who 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 Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I (Placebo)<br>Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg. | Drug: Placebo<br>* Patients in the placebo group will receive placebo medication.<br>|
| Experimental: Group II (Ustekinumab 45 mg)<br>Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. | Drug: Ustekinumab<br>* Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).<br>* Other names: CNTO 1275;Drug: Placebo<br>* Patients in the placebo group will receive placebo medication.<br>|
| Experimental: Group III (Ustekinumab 90 mg)<br>Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. | Drug: Ustekinumab<br>* Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).<br>* Other names: CNTO 1275;Drug: Placebo<br>* Patients in the placebo group will receive placebo medication.<br>|
| Experimental: Group IV<br>Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo. | Drug: Ustekinumab<br>* Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).<br>* Other names: CNTO 1275;|
| Experimental: Group V<br>Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo. | Drug: Ustekinumab<br>* Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).<br>* Other names: CNTO 1275;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12 | Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score. | Week 12 | 
| Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. 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 32 | 
| Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28 | Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. 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 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, CNTO 1275, Ustekinumab, Stelara, Interleukin-12, IL-12, Interleukin-23, IL-23