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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320216
• Other study ID #: CR005416
• Secondary ID: C0379T04
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2006
• Last updated: March 31, 2015
• Start date: November 2003
• Est. completion date: March 2005

Study information

• Verified date: March 2015
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00322998

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
• Placebo
Patients in the placebo group will receive placebo medication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No