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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00320216
First received: April 28, 2006
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Ustekinumab
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    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.


Enrollment: 320
Study Start Date: November 2003
Study Completion Date: March 2005
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group I (Placebo)
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
Patients in the placebo group will receive placebo medication.
Experimental: Group II (Ustekinumab 45 mg)
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
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Other Name: CNTO 1275
Drug: Placebo
Patients in the placebo group will receive placebo medication.
Experimental: Group III (Ustekinumab 90 mg)
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
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Other Name: CNTO 1275
Drug: Placebo
Patients in the placebo group will receive placebo medication.
Experimental: Group IV
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
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Other Name: CNTO 1275
Experimental: Group V
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
Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).
Other Name: CNTO 1275

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320216

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00320216     History of Changes
Obsolete Identifiers: NCT00322998
Other Study ID Numbers: CR005416, C0379T04
Study First Received: April 28, 2006
Results First Received: October 23, 2009
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Psoriasis
CNTO 1275
Ustekinumab
Stelara
Interleukin-12
IL-12
Interleukin-23
IL-23

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 25, 2014