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

Centocor Ortho Biotech

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Ustekinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320216

CR005416

C0379T04 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 5 patient groups, including a placebo group

Group I (Placebo)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Group II (Ustekinumab 45 mg)

Experimental group

Description:

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.

Treatment:

Drug: Ustekinumab

Drug: Placebo

Group III (Ustekinumab 90 mg)

Experimental group

Description:

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.

Treatment:

Drug: Ustekinumab

Drug: Placebo

Group IV

Experimental group

Description:

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.

Treatment:

Drug: Ustekinumab

Group V

Experimental group

Description:

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.

Treatment:

Drug: Ustekinumab