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A Study of the Safety and Efficacy of CNTO 1275 in Patients With Severe Plaque-Type Psoriasis
This study is ongoing, but not recruiting participants.
First Received: December 20, 2005   Last Updated: March 26, 2009   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00267969
  Purpose

The primary purpose of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: CNTO 1275
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of CNTO 1275in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The primary endpoint is the proportion of patients who achieve >= 75% improvement in the psoriasis area-and-severity index from baseline at Week 12.

Secondary Outcome Measures:
  • Major secondary endpoints are the proportions of patients with clear or minimal disease at Week 12 by Physician Global Assessment, the improvement in the Dermatology Life Quality Index, and benefit:risk profile of maintenance therapy.

Estimated Enrollment: 750
Study Start Date: December 2005
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Although numerous therapeutic options exist for the treatment of psoriasis, significant unmet medical needs for effective therapies with limited toxicity and side effects. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously (under the skin) as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that CNTO 1275 will be more effective in treatment of psoriasis than placebo, that the improvement in psoriasis will result in an improved quality of life for treated patients and that CNTO 1275 will be generally well tolerated. Patients will be randomized to long term extension of the study during which subjects will continue to receive treatment with CNTO 1275 and will be followed for a total of up to 264 weeks from the initial (week 0) administration of study agent. This study will remain blinded through the Week 76 database lock.

The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For patients who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks.

  Eligibility

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

Inclusion Criteria:

  • Plaque-type psoriasis diagnosed > 6 months prior
  • Plaque-type psoriasis covering at least 10% of total body surface areas
  • Psoriasis area-and-severity index score of >=12
  • 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 controlmeasures
  • Have no history of latent or active TB

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 any therapeutic agent targeted at reducing IL-12 or IL-23
  • Patients who have had a BCG vaccination within the previous 12 months
  • 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
  • Subjects 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
  • Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
  • Patients participating in another trial using an investigational agent or procedure.Systemic immunosuppressants within 4 weeks of the first administration of study agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267969

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 National Clinical Trials Identifier (NCT ID):
Study ID Numbers: CR006328
Study First Received: December 20, 2005
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00267969     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
interleukin-23
IL-23
interleukin 23
CNTO1275
biologic
Psoriasis
IL12
CNTO 1275
IL23
IL-12
interleukin-12
interleukin 12

Study placed in the following topic categories:
Interleukin-12
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

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

ClinicalTrials.gov processed this record on July 02, 2009